Spinal Cord Injury
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICERehabilitation using REX
Exercises of wheelchair dependent subjects using REX
Sponsors
Generic Devices Consulting, Inc.
Rex Bionics Plc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Transfer | 1 day | Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX |
| Adverse Events | 1 day | absence of unexpected serious adverse events |
| Transfer Time | 1 day | Time it took for participant to transfer into the Rex with or without supervision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction Questionnaire | 1 Day | overall user satisfaction with the device |
| Timed up and go Test- Ability to Stand From Chair | 1 Day | The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test) |
Countries
Australia, New Zealand, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rehabilitation Using REX Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | Rehabilitation Using REX |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 39.8 years |
| Region of Enrollment Australia | 44 participants |
| Region of Enrollment New Zealand | 3 participants |
| Region of Enrollment United Kingdom | 9 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
Primary
Ability to Transfer
Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX
Time frame: 1 day
Population: All subjects meeting inclusion criteria. Physically able to properly fit in REX.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rehabilitation Using REX | Ability to Transfer | 32 participants |
Primary
Adverse Events
absence of unexpected serious adverse events
Time frame: 1 day
Population: All patients transferring into Rex.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rehabilitation Using REX | Adverse Events | 56 Participants |
Primary
Transfer Time
Time it took for participant to transfer into the Rex with or without supervision.
Time frame: 1 day
Population: All patients transferring into Rex
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Using REX | Transfer Time | 352.2 seconds | Standard Deviation 75 |
Secondary
Participant Satisfaction Questionnaire
overall user satisfaction with the device
Time frame: 1 Day
Population: Patients who were able to transfer into REX and who could control the joystick. One patient was unable to walk and control Rex so did not complete the questionaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Easy to Transfer % positive | 57 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Confidence % positive | 91 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Safety % positive | 88 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Stability % positive | 89 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Ease of control % positive | 84 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Comfort % positive | 84 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Wellbeing following use % positive | 82 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | Benefits to using regularly % positive | 91 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | The size of REX did not bother me | 64 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | The sound of REX did not bother me % positive | 73 percentage of patients |
| Rehabilitation Using REX | Participant Satisfaction Questionnaire | The speed of REX was suitable for me % positive | 61 percentage of patients |
Secondary
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)
Time frame: 1 Day
Population: Subjects who were able to control the joystick. One patient was unable to control the joystick and was excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Using REX | Timed up and go Test- Ability to Stand From Chair | 316.41 seconds | Standard Deviation 91.52 |