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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
International Spinal Research Trust
Alberta Heritage Foundation for Medical Research
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT00656149
First received: April 1, 2008
Last updated: November 15, 2011
Last verified: November 2011
  Purpose
  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.

Condition Intervention Phase
Spinal Cord Injury
Quadriplegia
Tetraplegia
Behavioral: FES-assisted In-home telerehabilitation of hand function
Behavioral: Exercise training
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome Evaluation of Exercise and Electrical Therapy for Quadriplegic Hand Function

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Action Research Arm Test [ Time Frame: every 2 weeks during therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transcranial magnetic stimulation [ Time Frame: every 2 weeks during therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
FES-assisted hand exercises on a workstation.
Behavioral: FES-assisted In-home 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: 2
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).
Behavioral: Exercise training
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
  • Therapeutic electrical stimulation (TES)
  • Intensive exercise therapy
  • Massed practice

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656149

Locations
Canada, Alberta
Centre for Neuroscience, University of Alberta
Edmonton, Alberta, Canada, T6C1M8
Sponsors and Collaborators
University of Alberta
International Spinal Research Trust
Alberta Heritage Foundation for Medical Research
Investigators
Principal Investigator: Arthur Prochazka University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT00656149     History of Changes
Other Study ID Numbers: SCI-IHT, ISRT-G700000249 PY107
Study First Received: April 1, 2008
Last Updated: November 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
telerehabilitation
functional electrical stimulation
spinal cord injury
hand function rehabilitation

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Wounds and Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014