N/A
Completed N=56
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Source: ClinicalTrials.gov NCT02417532 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Ability to Transfer — 32 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability to Transfer |
32 | — |
| PRIMARY Adverse Events |
56 | — |
| PRIMARY Transfer Time |
352.2 | — |
| SECONDARY Participant Satisfaction Questionnaire |
57; 91; 88; 89; 84; 84 | — |
| SECONDARY Timed up and go Test- Ability to Stand From Chair |
316.41 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02417532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.