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In-home Telerehabilitation for Quadriplegic Hand Function (SCI-IHT)

Primary Purpose

Spinal Cord Injury, Quadriplegia, Tetraplegia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Telerehabilitation of hand function
Conventional exercise therapy
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring telerehabilitation, functional electrical stimulation, spinal cord injury, hand function rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic C5, 6 or 7 SCI subjects who have sustained a cervical SCI resulting in complete or incomplete quadriplegia. Time since injury at least one year at time of entry to study. Subjects may have a complete or an incomplete injury but must demonstrate loss of finger grasp and release as well as loss of thumb lateral (key) pinch bilaterally or unilaterally. Subjects must be stable neurologically and medically, cognitively intact, and willing and able to attend the requisite appointments for participation in the study.

Exclusion Criteria:

  • Subjects with unresolved medical issues such as easily triggered autonomic dysreflexia and/or hypotension.
  • Subjects demonstrating severe spasticity affecting the upper extremities, fixed hand contractures with loss of suppleness and range of movement at the metacarpal-phalangeal joints, absence of voluntary ability to extend the wrist against gravity and/or insufficient muscle strength to abduct (lift) the arm against gravity.
  • Subjects with unresolved substance abuse problems
  • Subjects with a history of head injury, epilepsy in self or close relative and/or cognitive impairment
  • Subjects with intracranial metal inclusions
  • Subjects, who upon initial testing, demonstrate partial or complete denervation (loss of nerve supply) of the nerves to the the targeted muscle.

Sites / Locations

  • Centre for Neuroscience, University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Telerehabilitation of hand function

Conventional exercise therapy

Arm Description

Intervention: for one hour per day participants perform exercise therapy on a home-based tele-rehabilitation workstation, the Rehabilitation Joystick for Computerized Exercise (ReJoyce) with which participants play computer games associated with activities of daily life. A remote therapist coaches each one-hour session over the Internet, with the use of the ReJoyce tele-rehabilitation system. Hand grasp-release is assisted with functional electrical stimulation (FES) triggered voluntarily by the participant with the use of a wireless earpiece with a sensor that detects toothclicks.

Intervention: for one hour per day participants perform conventional range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 with the use of the ReJoyce tele-rehabilitation min). A remote therapist coaches each one-hour session A remote therapist coaches each one-hour session over the Internet, with the use of the ReJoyce tele-rehabilitation system.

Outcomes

Primary Outcome Measures

Action Research Arm Test

Secondary Outcome Measures

Transcranial magnetic stimulation

Full Information

First Posted
April 1, 2008
Last Updated
January 10, 2017
Sponsor
University of Alberta
Collaborators
International Spinal Research Trust, Alberta Heritage Foundation for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00656149
Brief Title
In-home Telerehabilitation for Quadriplegic Hand Function
Acronym
SCI-IHT
Official Title
Outcome Evaluation of Exercise and Electrical Therapy for Quadriplegic Hand Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
International Spinal Research Trust, Alberta Heritage Foundation for Medical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate improvements in hand function in stable, cervical spinal cord injured (SCI) subjects treated with functional electrical stimulation (FES)-assisted exercise; To compare the information obtained from existing qualitative and quantitative hand function tests with newly developed tests of sensorimotor performance. Hypotheses: the performance of tasks representative of activities of daily living (ADL) will improve with daily tele-supervised exercise of the affected hand. The improvements will be greater in one exercise protocol than the other, the protocols being a) FES-assisted exercise on a workstation, b) cyclical FES, weight training and precision tasks. Scores derived from quantitative data obtained from sensors on the workstation will correlate with the qualitative scores of the primary outcome measure, the ARAT hand function test.
Detailed Description
Chronic C5, 6 or 7 SCI subjects who have sustained a cervical SCI resulting in complete or incomplete quadriplegia. Time since injury at least one year at time of entry to study. Subjects may have a complete or an incomplete injury but must demonstrate loss of finger grasp and release as well as loss of thumb lateral (key) pinch bilaterally or unilaterally. Subjects must be stable neurologically and medically, cognitively intact, and willing and able to attend the requisite appointments for participation in the study. Two treatments, each delivered 1 hour per day, five days a week over six weeks are given in a randomized order. Treatment A Subjects perform 1 hour per day of FES-assisted hand exercises on an instrumented exercise workstation in their homes, supervised remotely over the Internet. Four manipulanda in the workstation are used per exercise session. Each manipulandum is an object such as a spring-loaded doorknob, representing a task of daily life. As their motor skills improve over consecutive sessions, subjects are presented with manipulanda of increasing difficulty. A muscle stimulator garment is provided to each subject for FES-assisted exercise (Prochazka et al. 1997b). Hand opening and closing are wirelessly triggered from an earpiece that detects small voluntary tooth-clicks. The stimulator system is CSA-approved. Treatment B Subjects perform the following tasks 1 hour per day in their homes, supervised remotely over the Internet. 20 minutes of weight training: range of motion (ROM) movements while wearing a wristlet, the weight of which is selected so as to reduce the ROM at maximum effort by about 50%. 20 minutes of accuracy training using a large computer mouse to play simple and enjoyable computer games that provide subjects with feedback on their performance. 20 minutes of therapeutic electrical stimulation (TES). This consists of ON-OFF cyclical stimulation of hand muscles with the stimulator garment, e.g. while subjects watch TV. The outcome measures are tested at 2-week intervals and require visits to the Center for Neuroscience at the University of Alberta. A maximum of CDN$2,000 is available to reimburse participants' travel and accommodation costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Quadriplegia, Tetraplegia
Keywords
telerehabilitation, functional electrical stimulation, spinal cord injury, hand function rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation of hand function
Arm Type
Active Comparator
Arm Description
Intervention: for one hour per day participants perform exercise therapy on a home-based tele-rehabilitation workstation, the Rehabilitation Joystick for Computerized Exercise (ReJoyce) with which participants play computer games associated with activities of daily life. A remote therapist coaches each one-hour session over the Internet, with the use of the ReJoyce tele-rehabilitation system. Hand grasp-release is assisted with functional electrical stimulation (FES) triggered voluntarily by the participant with the use of a wireless earpiece with a sensor that detects toothclicks.
Arm Title
Conventional exercise therapy
Arm Type
Active Comparator
Arm Description
Intervention: for one hour per day participants perform conventional range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 with the use of the ReJoyce tele-rehabilitation min). A remote therapist coaches each one-hour session A remote therapist coaches each one-hour session over the Internet, with the use of the ReJoyce tele-rehabilitation system.
Intervention Type
Procedure
Intervention Name(s)
Telerehabilitation of hand function
Other Intervention Name(s)
In-home telerehabilitation, Functional electrical stimulation (FES), Intensive exercise therapy, Massed practice
Intervention Description
6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
Intervention Type
Procedure
Intervention Name(s)
Conventional exercise therapy
Other Intervention Name(s)
In-home telerehabilitation, Therapeutic electrical stimulation (TES), Intensive exercise therapy, Massed practice
Intervention Description
For one hour per day subjects perform range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 min).
Primary Outcome Measure Information:
Title
Action Research Arm Test
Time Frame
every 2 weeks during therapy
Secondary Outcome Measure Information:
Title
Transcranial magnetic stimulation
Time Frame
every 2 weeks during therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic C5, 6 or 7 SCI subjects who have sustained a cervical SCI resulting in complete or incomplete quadriplegia. Time since injury at least one year at time of entry to study. Subjects may have a complete or an incomplete injury but must demonstrate loss of finger grasp and release as well as loss of thumb lateral (key) pinch bilaterally or unilaterally. Subjects must be stable neurologically and medically, cognitively intact, and willing and able to attend the requisite appointments for participation in the study. Exclusion Criteria: Subjects with unresolved medical issues such as easily triggered autonomic dysreflexia and/or hypotension. Subjects demonstrating severe spasticity affecting the upper extremities, fixed hand contractures with loss of suppleness and range of movement at the metacarpal-phalangeal joints, absence of voluntary ability to extend the wrist against gravity and/or insufficient muscle strength to abduct (lift) the arm against gravity. Subjects with unresolved substance abuse problems Subjects with a history of head injury, epilepsy in self or close relative and/or cognitive impairment Subjects with intracranial metal inclusions Subjects, who upon initial testing, demonstrate partial or complete denervation (loss of nerve supply) of the nerves to the the targeted muscle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Prochazka
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Neuroscience, University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6C1M8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21372246
Citation
Kowalczewski J, Chong SL, Galea M, Prochazka A. In-home tele-rehabilitation improves tetraplegic hand function. Neurorehabil Neural Repair. 2011 Jun;25(5):412-22. doi: 10.1177/1545968310394869. Epub 2011 Mar 3.
Results Reference
result

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In-home Telerehabilitation for Quadriplegic Hand Function

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