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| Name | Class |
|---|---|
| Generic Devices Consulting, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation using REX | Experimental | Exercises using Rex mobility assist device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation using REX | Device | Exercises of wheelchair dependent subjects using REX |
|
| 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 |
| 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) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas C Birch, FRCS | The Chris Moody Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Health | Heidelberg | Victoria | 3084 | Australia | ||
| Rehabilitation Innovation Centre at AUT University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28629390 | Derived | Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rex Rehabilitation Patients | Tetraplegic and paraplegic patients able to use REX. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rehabilitation Using REX | Exercises using Rex mobility assist device Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age - from date of birth record |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ability to Transfer | Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX | All subjects meeting inclusion criteria. Physically able to properly fit in REX. | Posted | Number | participants | 1 day |
|
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rehabilitation Using REX | All patients who were able to transfer into a Rex with or without assistance. |
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Patients enrolled under at different times in the recruitment process had differing lengths of follow-up as reflected in the final study report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Birch | The Chris Moody Centre | +44 1604 215440 | nickbirch@doctors.org.uk |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 1 Day |
| Auckland |
| 1010 |
| New Zealand |
| Canterbury District Health Board, Burwood Hospital | Christchurch | 4708 | New Zealand |
| East Kent Hospitals University Foundation Trust | Canterbury | Kent | CT1 3NG | United Kingdom |
| Royal National Orthopaedic Hospital NHS Trust | Stanmore | Middlesex | WD6 4QY | United Kingdom |
| Physiofunction | Moulton | Northamptonshire | NN37rr | United Kingdom |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Adverse Events | absence of unexpected serious adverse events | All patients transferring into Rex. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Primary | Transfer Time | Time it took for participant to transfer into the Rex with or without supervision. | All patients transferring into Rex | Posted | Median | Standard Deviation | seconds | 1 day |
|
|
|
| Secondary | Participant Satisfaction Questionnaire | overall user satisfaction with the device | 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. | Posted | Number | percentage of patients | 1 Day |
|
|
|
| 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) | Subjects who were able to control the joystick. One patient was unable to control the joystick and was excluded. | Posted | Mean | Standard Deviation | seconds | 1 Day |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
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| D014947 | Wounds and Injuries |
| Title |
|---|
| Measurements |
|---|
|
| Stability % positive |
|
| Ease of control % positive |
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| Comfort % positive |
|
| Wellbeing following use % positive |
|
| Benefits to using regularly % positive |
|
| The size of REX did not bother me |
|
| The sound of REX did not bother me % positive |
|
| The speed of REX was suitable for me % positive |
|