2.3.4.1 Body-Weight Support Treadmill Training (BWSTT)

2.3.4 Intervention 2.3.4.1 Body-weight support treadmill training (BWSTT) 2.3.4.1.1 Procedure

DRAFT- June 16/2003

I. PARTICIPANT MANAGEMENT

1. Participant Attire  If the participant has been randomized to a group that includes body weight support treadmill training, the participant should be advised PRIOR to the first session what to wear for the training.  The participant must wear shorts, as this facilitates proper hand placements by the trainers.  Male patients are encouraged to wear athletic supporters to protect the genitals from pinching and possible injury from the harness.  The participant is advised to wear lightweight tennis shoes while on the treadmill. The purpose of the footwear is to provide traction, foot support and maximize ankle mobility (ie: tennis shoes preferred over high top basketball shoes or hiking boots)  The participant will NOT wear an AFO while on the treadmill during training. The physical therapist will manually provide stability at the participant’s ankle throughout the gait cycle and ensure that the participant’s ankle is never at risk for injury. In rare circumstances when the physical therapist feels that he/she can not provide maximal control at the participant’s ankle, and feels that the participant’s ankle may be at risk for injury, then the AFO may be considered.

2. Harness Application  The harness consists of two parts: the vest and the pelvic belt.  Correct fit of the harness is essential for success in training. Time should be taken the first day to create a harness that fits the participant correctly. Correct fit of the harness is determined by: 1. The participant’s subjective comfort. 2. Symmetrical trunk alignment (the vest is not rotated on the subject, and the subject is able to stand upright in maximum available trunk extension). 3. A secure, snug fit around the thorax and pelvis, therefore preventing the harness from “riding up” on the participant once he/she is unweighted on the treadmill.  There are 3 sizes of both the vest and the pelvic belt: small, medium and large. The vest and the pelvic belt can be interchanged - ie: a participant may require a small vest and a medium pelvic belt to fit his/her body correctly.

1. Positioning the participant to put on the harness.

STEPS MOP 4/6/2018 1  It is best to fit the harness while the participant is standing. If the participant is unable to stand, then the harness can be put on while the participant is supine on a mat. If the participant is supine, either have the participant bridge, or assist the participant in rolling side to side, to correctly position the harness.

2. Fit of the harness. a. Pelvic belt placement:  The placement of the pelvic belt should be symmetrical, with support distributed evenly around the pelvis, without limiting hip extension.  Align the top of the pelvic belt just above the ASIS. The bottom of the vest should touch the ASIS.  Position the back loop of the pelvic belt at the center of the sacrum.  Secure the buckle of the anterior horizontal strap so the belt firmly holds the pelvis. b. Vest Placement:  Ensure that the 4 bands (two anterior, two posterior) between the pelvic belt and the vest ARE PULLED TIGHT (ie: shortened to their endpoint.) This will prevent the vest from "riding up" once the participant is attached to the overhead harness and unweighted.  The bottom of the vest should be just on, or above the ASIS bilaterally.  Center the rear handle of the vest below and between the scapula.  Position the two longitudinal straps of the vest that attach to the overhead harness, around the midline of the chest. Ensure that the buckle on the longitudinal strap (that attaches to the overhead harness) is over the shoulder joint. To increase trunk extension in a participant, position this buckle ANTERIOR to the shoulder joint.  Secure the buckles of the two anterior straps so that the vest FIRMLY grips the rib cage, but doesn't impede respiration.  If the anterior straps on the vest are at their endpoints once secured (ie: too short, or too long) you may need to pick a larger or smaller vest. c. Leg strap placement:  Apply the legs straps one at a time. If the participant is supine, attach the leg strap while the hip and knee are flexed (ie: bridging position.)  In men, have the participant move his genitals away from the straps to avoid pinching.

STEPS MOP 4/6/2018 2  Secure the buckle of the strap so that it fits snuggly. This is very important in order to prevent the harness from riding up when the participant is unweighted.  Use elbow pads over the straps in areas of discomfort.

3. Participant Placement On The Treadmill  If the participant is in a wheelchair: 1. Wheel the participant up the ramp, and position the participant underneath the overhead suspension. 2. Stand the participant up, and attach the overhead suspension to the buckles on the longitudinal straps of the harness vest. (Computer must be on and body weight support must be at 0 pounds.) 3. Attach the bungees to the participant. Once the bungees are attached, remove the wheelchair and position it on the ramp.

* The clinician must be with the participant at ALL TIMES during the set up on the body weight support treadmill to ensure participant safety. If the participant voices that he/she is uncomfortable, or the clinician recognizes signs of participant discomfort (ie: rapid change in heart rate/blood pressure, or skin pallor) sit the participant back down in the wheelchair and immediately reassess vitals.

4. Unweight the participant to the desired body weight. 5. Press “Step Patient” on the computer. The system is now ready to begin treadmill training.

 If the participant is not in a wheelchair: 1. Assist the participant as necessary to ambulate up the ramp and onto the treadmill. 2. Attach the overhead suspension to the buckles on the longitudinal straps of the harness vest. (Computer must be on and body weight support must be at 0 pounds.) 3. Attach the bungees to the participant. Ensure that a chair is positioned on the ramp so it is available if the participant needs to sit down.

STEPS MOP 4/6/2018 3 4. Unweight the participant to the desired body weight. 5. Press “Step Patient” on the computer. The system is now ready to begin treadmill training.

 When the participant has completed stepping for that session: 1. Press “Position Patient” on the computer screen. 2. Lower the body weight support to 0 pounds. 3. Have another person position a wheelchair/chair behind the participant. 4. Assist the participant to stand, and remove the bungees, one at a time. 5. Remove the overhead suspension from the harness vest buckles. 6. Assist the participant to sit down in the chair. If the participant ambulated up to the treadmill, let him/her rest for a few minutes, then assist in ambulating down the ramp.

4. Monitoring Participant Response To Exercise: 1. Cardiovascular response Cardiovascular measurements should be taken prior to beginning exercise, during exercise and post exercise.  Baseline: sitting HR and BP (if indicated), standing HR and BP  Post-exercise bout 1 (5 minutes): HR and BP  Post-exercise bouts (after bout 1): HR only unless participant seems in distress then BP  End of session: HR and BP

If any of the following abnormal cardiac responses occur, exercise should be stopped and a physician should be notified: a) Systolic blood pressure drops > 10 mm Hg from resting, standing BP b) Systolic blood pressure rises to > 250 mm Hg c) Diastolic blood pressure rises to >120 mm Hg d) Heart rate drops more than 15 bpm provided the participant was stepping the last minute of the test (as opposed to resting).

2. Motor response:  If the participant demonstrates signs of motor fatigue (ie: decrease in limb coordination, increase in patterned movement, increase in tone, and/or increase in trainer assistance to support stance or swing), the participant should be asked if he/she needs a rest. o If the participant answers “YES”, pause the treadmill and reassess the participant’s vitals. Exercise should not resume until vitals are within baseline parameters. If the participant is taking excessive time to return to baseline parameters, or abnormal cardiac responses are occurring (see parameters

STEPS MOP 4/6/2018 4 above) or the clinician (with his/her clinical expertise) determines that it is not safe for the participant to continue exercising, the exercise will be terminated. The clinician will document on the data form the reason for discontinuing exercise. o If the participant answers “NO”, then the clinician must decide whether the participant requires a rest, or requires increased verbal/manual commands to improve the motor response. If the clinician chooses to continue exercise with increased verbal/manual commands, then a change in the participant’s motor response should be seen within 4 steps, or a rest should be taken.  A rest should also be taken if the participant requests to stop.

3. Other participant requests:  Other reasons which may stop exercise, or have the participant take a rest and reassess the treatment session, include, but are not limited to; the participant requesting to go to the bathroom, the participant states that she/he is not feeling well, or the participant complains of pain.

II. TRAINERS

1. Hip Trainer  The hip trainer is responsible for establishing and maintaining proper participant position/alignment and control of the pelvis.  The head, shoulders, hips and feet should be directly aligned under the support cable throughout stepping. This can be observed by the hip trainer by positioning a mirror beside the treadmill.  The trainer stands approximately eight inches behind the participant, and firmly grasps the harness vest handles. There are three possible hand positions: 1. Rear handle of vest and one lateral loop of pelvic band. 2. Read handle of vest and rear loop of pelvic band. 3. Both lateral loops of pelvic band.  In the different phases of gait, the hip trainer assists the participant’s pelvis as necessary to achieve the pelvic movements that occur with normal gait kinematics. 1. During stance phase, the hip trainer may assist the participant in rotating the pelvis backward. 2. During stance to swing transition, the hip trainer may assist the participant in weight shifting to the contralateral leg. 3. During swing phase, the hip trainer may assist the participant in rotating the pelvis forward.

STEPS MOP 4/6/2018 5  As necessary, the hip trainer may also limit the pelvis from tilting laterally, anteriorly, and posteriorly, while assisting the pelvis to rotate along the longitudinal axis during stepping.  Proper body mechanics for the hip trainer include having him/her keep his/her arms rigid while rotating his/her own body simultaneously with the participant.  The participant is not permitted to lean back on the hip trainer. If the hip trainer is necessary in stepping (see below for progression), the only contact between the hip trainer and the participant should be the trainer’s hands.

2. Leg Trainer  The leg trainer is responsible for appropriately assisting the participant’s lower extremity to achieve normal gait kinematics throughout all phases of gait.

Hand Position: The trainer’s outside, upper hand, is positioned posteriorly at the participant’s knee to facilitate flexion in push off and swing, and then rotated anteriorly to the patellar tendon to facilitate knee extension in stance. The trainer’s inside, lower hand, is positioned on the dorsum of the participant’s ankle to facilitate ankle plantarflexion at push off and dorsiflexion through swing and heel strike.

Example of Hand Position:

 STANCE PHASE (extension of hip and knee): Upper hand: Facilitate knee extension by placing web of hand at anterior, proximal tibia on the patellar tendon. Provide just enough force to achieve knee extension, but NOT hyperextension. Lower hand: Stabilize the dorsum of the foot, controlling eversion/inversion.

 STANCE TO SWING TRANSITION: Upper hand: Facilitate knee flexion by rotating you hand from the anterior tibia to the lateral hamstring tendon (laterally and upwardly). Press on the lateral hamstring tendon with two fingers. Lower hand: Initially, provide some pressure through the dorsum of the foot to encourage push off. Then, either stay at the dorsum of the foot, and facilitate dorsiflexion for toe clearance, or transition your hand to the participant’s heel and cue dorsiflexion. If at the heel, keep fingers open and AVOID grasping the achilles tendon.

 SWING:

STEPS MOP 4/6/2018 6 Upper hand: Guide the knee forward only using pressure at the back of the knee. Do not LIFT the leg or grab the calf. At terminal swing, start to rotate the hand to the front of the knee. Lower hand: Maintain same position as stance to swing transition.

 SWING TO STANCE TRANSITION Upper hand: Finish rotating your hand to the front of the knee, and facilitate knee extension at heel strike by gently pressing on the proximal tibia at the patellar tendon. Lower hand: Facilitate heel strike, then position hand on dorsum of foot for stance.

4. Treadmill/Computer Operator  Ensure that the computer is at “STEP PATIENT” before commencing stepping.  Press start on the treadmill, and increase speed to desired value as requested by the clinician.  Monitor computer screen during stepping. If “end point proximity” appears on the computer screen, alert the clinician, and pause the treadmill.  During a treatment session, never press “STOP” on the treadmill. Press “PAUSE”, as this will preserve the cumulative time.  In an EMERGENCY, pull the red magnet off the treadmill to stop it. This red magnet must be connected to the treadmill at all times for the treadmill to operate. If “SAFETY” appears on the treadmill screen and you are unable to increase the treadmill speed, check that the red magnet is attached securely.  Record on the participant’s data sheet treadmill speed, rests, body weight support, heart rate and blood pressure during the treatment.

III. TREATMENT SESSION AND PROGRESSION

For the purpose of STEPS, the goal of each treatment session is to have the participant step four, 5 minute walking bouts (total of 20 minutes) at 2.0 mph with rests only between each 5 minute bout using proper gait kinematics for stance and swing (upright posture, extending/flexing the knee, hip and ankle and coordinating limb movements to achieve symmetrical limb cadence and equal step length).

The body weight support (BWS) for the initial session is initially set at 40% of the participant’s body weight. However, if the participant is unable to support his/her weight during stance, the BWS can be increased. Body weight support must be recorded for each session, and a comment must be included if the BWS is greater than 40%. BWS will be increased or decreased in 5% increments.

STEPS MOP 4/6/2018 7 The speed of the treadmill should be maintained at 2.0 mph. Subjects are permitted to rest as often as necessary during a 5 minute bout. However, the primary goal of walking a 5 minute bout with no rests must be kept in mind. Therefore, it is imperative to record the number of rests the participant takes during a 5 minute bout, and each session try to improve on this (ie: decrease number of rests.) If a participant is UNABLE to walk at 2mph, which is observable when the participant is unable to achieve proper gait kinematics with 40% BWS and maximum hip/leg trainer support, then the speed can be decreased in 0.2 mph increments until a speed facilitating proper gait kinematics with maximum support is found. The therapist should detail in the comments section on the data form the reason for the decrease in speed.

Progression Guidelines: Progression on the body weight support treadmill system can occur in several ways. However, when you start progressing a participant, remind yourself of the primary goal for the body weight support treadmill training:

Enabling the participant to step four, 5 minute walking bouts (total of 20 minutes) at 1.8 – 2.2 mph (average speed around 2.0 mph) with rests only between each 5 minute bout using proper gait kinematics for stance and swing (upright posture, extending/flexing the knee, hip and ankle and coordinating limb movements to achieve symmetrical limb cadence and equal step length).

1. Progressing BWS: If the participant is able to step four, 5 minute walking bouts at an average speed of 2.0 mph, using proper gait kinematics, and only resting between each 5 minute bout, then the body weight support can be decreased. The BWS should be decreased in 5% increments. The primary goal of the body weight support treadmill training should then be achieved at this decreased body weight support.

2. Removing proximal support: This can be achieved by removing the assistance given to the participant by the hip trainer, or removing the bungee support. The bungees are usually not removed until the participant has achieved the primary goal of body weight support treadmill training for the study, and is at 10-15% BWS.

3. Independent participant stepping: The leg trainer should decrease the manual assistance/cueing that is being given to the participant with the goal being for the participant to step independently. The trainer’s proximal hand support is removed first, followed by the distal hand support.

The above points are simply GUIDELINES to progress a participant on the body weight support treadmill intervention – there is not a recipe to follow. What must

STEPS MOP 4/6/2018 8 be kept in mind at all times during progression is the primary goal of the intervention. Furthermore, there may be regressions in one area, to achieve progressions in another.

For example:

 If a participant is having a very difficult time decreasing the number of rests during a 5 minute bout, then the body weight support may be increased to 45% to achieve the goal of four, 5 minute walking bouts with only a rest between bouts while maintaining proper gait kinematics.

 A participant is at 30% BWS, and is appropriate for progression, but still relies occasionally on the hip trainer during stance for pelvic stability. Instead of decreasing the BWS as a progression, you may choose to maintain the BWS at 30%, and remove the hip trainer’s assistance to challenge the participant’s pelvic control.

With any progression, continually reassess how it is assisting you in achieving the primary goal of body weight support treadmill training for STEPS.

IV. BWSTT SYSTEM OPERATION (USC Robomedica System)

1. Turn on the computer and screen.  User Name: Administrator Password: (There is no password)  Open "Body Weight Support" icon.  Now proceed to step 2.

2. OPEN the gas tank all the way. Do not touch the other dials.  GAS TANK PRESSURE MUST BE ABOVE 500. Do not start a participant if you are at 600 or below. If you are at 600 or below, you must change tanks. Please see the following page on how to change the tank.  SOURCE PRESSURE SHOULD BE AT 140. IT MUST BE ABOVE 120 AND BELOW 150. You should never have to touch this dial.

3. Turn blue knob on body weight support frame clockwise to "OPEN". You will hear initial gas entry and then a 2nd "whistle". This will take approximately 8 seconds. DO NOT proceed until you hear that 2nd "whistle".

4. At the computer, click the red button "OFF" in the top left hand corner. This button will turn green, and turn the system "ON".

STEPS MOP 4/6/2018 9 In the bottom right hand corner, there is a switch that says "Position Patient" and "Step Patient". Think of that icon like a light switch. At this stage, the switch should be "on" at "Position Patient."

5. You are now ready to get your participant onto the system. The body weight support should be at ZERO. Pull the body weight support spreader bar down, and attach it to the shoulder buckles on the harness vest. Adjust the safety line so it is the appropriate length for the participant. There should always be a chair on the ramp just incase of an emergency if you had to sit the participant down immediately.

6. Attach the bungees to the participant. The bungees cross the participant in the front and the back and attach to the big loop on each side of the pelvic belt.

7. Set the body weight support to the desired value. The body weight support can be increased by increasing the bar on the weight support.

8. Now that you have the desired body weight support, you are ready to step the participant. Press "Step Patient" and the switch should turn down to this position.

9. Press start on the treadmill and increase it to the desired speed. If you need to stop the treatment during the session, press PAUSE on the treadmill and this will preserve the total time the participant has stepped. If you press STOP, the time will clear.

10. If you want to increase or decrease the body weight during a session, pause the treadmill and press "Position Patient" on the computer. Change the body weight as needed. When you have the desired weight, press "Step Patient" and you can resume the treadmill.

If ENDPOINT PROXIMITY comes on the computer screen while you are stepping the participant, it means that the system needs to re-calibrate the body weight.  Pause the treadmill.  Move the switch on the computer to “Position Patient”  The system should re-calibrate within 5 seconds  Move the switch to “Step Patient" and resume stepping.

11. When you are finished stepping the participant, stop the treadmill. Have someone supervise the participant, while you go to the computer and press "Position Patient." Now, decrease the body weight to zero. Remove the bungees from the participant. Then, pull down on the body weight support spreader bar and unhook it from the participant’s harness vest. You can then take the harness vest and pelvic belt off in standing.

STEPS MOP 4/6/2018 10 12. Reposition the chair from the ramp to the treadmill, allowing the participant to sit and rest. Take HR and blood pressure as appropriate.

13. Once the participant is off the system, go to the computer and press the green "ON" button in the top left hand corner. This button will turn red and will now be "OFF". You can now close the program.

14. Turn the blue knob on the body weight support frame COUNTER CLOCKWISE to the off position.

15. At the gas tank, look at the readings on the gas tank dial. If the dial reads 600 or below, please change the tank (see following page for directions.) If the gas dial is above 600, completely close the gas tank (turning counterclockwise). Please double check to ensure that it is completely closed.

16. If you want to "bleed" the excess air out of the system, turn the blue knob on the body weight support frame clockwise to "open" once the gas tank is closed all the way. You will hear the gas leave the system, and the gas tank and source pressures will decrease to ZERO. Now, turn the blue knob counterclockwise to the "close" position.

17. Return to the computer. Close the Body Weight Support program. It will ask if you want to save the information. Press NO. In the lower left hand corner of the screen, click on start, and press "Shut down." The computer will prompt asking you if you really want to shut down. Press "Yes", and the computer will turn off.

18. If someone is going to use the treadmill system after you, but there is going to be a 10-15 minute time period between patients, do not turn the entire system off. Instead, you can go to the gas tank, and close it, therefore stopping the main source of gas. This will help to conserve gas. However, you MUST remember to open the tank before starting another participant.

19. EMERGENCY PROCEDURES: In an event of an emergency, please follow these steps when you have to take the participant off the body weight support immediately:

 STOP the treadmill, or pull the emergency switch on the treadmill. DO NOT PRESS THE EMERGENCY SWITCH ON THE BODY WEIGHT SUPPORT SYSTEM. If you accidentally press the emergency switch on the body weight support system, simply pull the switch up to disengage it.

STEPS MOP 4/6/2018 11  Press “Position Patient”

 LOWER THE BODYWEIGHT TO ZERO on the computer. DO NOT TURN THE TRAINING SYSTEM OFF (ie: on/off switch in top left hand corner of the screen) If you do this, the body weight harness will freeze where it is positioned. If you accidentally do this, press the button again, and the button should turn to the green, "ON" position.

 Take the chair from the ramp and position it underneath the participant on the treadmill. Take off the bungees, and pull down on the body weight support spread bar, removing the hooks from the participant's harness vest. Sit the participant in the chair. Loosen the harness vest and pelvic belt as necessary.

 Treat participant as needed.

STEPS MOP 4/6/2018 12