Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Study Overview
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Brief Summary
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Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.

Detailed Description
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The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.

Official Title
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Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Rehabilitation using REX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Wheelchair user Spinal Injury Levels of C4 down to L5 Has no outstanding skin integrity issues that could be effected by the REX device Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths: Upper leg length : 380 - 470 mm Lower leg length : 366 - 470 mm Heel position (Ankle to hind foot) : 40 - 92 mm Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm Has a skeletal hip width of 380 mm or less (limit imposed by REX) Is between 40 kg and 100 kg weight (limits imposed by REX) Has the manual dexterity to work a joystick Sufficient passive range of motion in the Hip, Knee and Ankle of at least Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction Knee 0 degrees extension 93 degrees flexion Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion Thigh lateral diameter of < 135 mm (230 mm above the knee joint line) Calf lateral diameter of < 100 mm (90 mm below the knee joint line) Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button No contraindications to standing or mobilising Patients must choose to participate, and must have signed the informed consent document Exclusion Criteria: Patients who do not meet inclusion criteria or physician discretion. Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function. Patients contraindicated to walk or stand Patients with spinal injury outside Inclusion criteria Withdrawal or refusal to sign informed consent Any other contraindication based on physician discretion Known allergy (skin contact) to materials used in Rex

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation using REX<br>Exercises using Rex mobility assist device | Device: Rehabilitation using REX<br>* Exercises of wheelchair dependent subjects using REX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to Transfer | Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX | 1 day | 
| Adverse Events | absence of unexpected serious adverse events | 1 day | 
| Transfer Time | Time it took for participant to transfer into the Rex with or without supervision. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction Questionnaire | overall user satisfaction with the device | 1 Day | 
| Timed up and go Test- Ability to Stand From Chair | The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test) | 1 Day |