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

January 10, 2017 updated by: University of Alberta

Outcome Evaluation of Exercise and Electrical Therapy for Quadriplegic Hand Function

  1. To evaluate improvements in hand function in stable, cervical spinal cord injured (SCI) subjects treated with functional electrical stimulation (FES)-assisted exercise;
  2. To compare the information obtained from existing qualitative and quantitative hand function tests with newly developed tests of sensorimotor performance.

Hypotheses:

  1. the performance of tasks representative of activities of daily living (ADL) will improve with daily tele-supervised exercise of the affected hand.
  2. 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.
  3. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

  1. 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%.
  2. 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.
  3. 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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6C1M8
        • Centre for Neuroscience, University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Telerehabilitation of hand function
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.
Procedure: Telerehabilitation of hand function
6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
Other Names:
  • In-home telerehabilitation
  • Functional electrical stimulation (FES)
  • Intensive exercise therapy
  • Massed practice
Active Comparator: Conventional exercise therapy
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.
Procedure: Conventional exercise therapy
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).
Other Names:
  • In-home telerehabilitation
  • Intensive exercise therapy
  • Massed practice
  • Therapeutic electrical stimulation (TES)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Action Research Arm Test
Time Frame: every 2 weeks during therapy
every 2 weeks during therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Transcranial magnetic stimulation
Time Frame: every 2 weeks during therapy
every 2 weeks during therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Alberta Heritage Foundation for Medical Research
International Spinal Research Trust

Investigators

  • Principal Investigator: Arthur Prochazka, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-IHT
  • ISRT-G700000249 PY107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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