In-home Telerehabilitation for Quadriplegic Hand Function

NCT00656149 | Completed Phase 2

• 2 other identifiers: SCI-IHTISRT-G700000249 PY107
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate improvements in hand function in stable, cervical spinal cord injured (SCI) subjects treated with functional electrical stimulation (FES)-assisted exercise;
2. 2.To compare the information obtained from existing qualitative and quantitative hand function tests with newly developed tests of sensorimotor performance.
3. 3.the performance of tasks representative of activities of daily living (ADL) will improve with daily tele-supervised exercise of the affected hand.
4. 4.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.
5. 5.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.

Conditions

Spinal Cord Injury; Quadriplegia; Tetraplegia

Keywords

telerehabilitation; functional electrical stimulation; spinal cord injury; hand function rehabilitation

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test

  every 2 weeks during therapy

Secondary Outcomes (1)

• Transcranial magnetic stimulation

  every 2 weeks during therapy

Study Arms (2)

Telerehabilitation of hand function

ACTIVE COMPARATOR

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

Conventional exercise therapy

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation of hand function PROCEDURE

6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.

Also known as: In-home telerehabilitation, Functional electrical stimulation (FES), Intensive exercise therapy, Massed practice

Telerehabilitation of hand function

Conventional exercise therapy PROCEDURE

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).

Also known as: In-home telerehabilitation, Therapeutic electrical stimulation (TES), Intensive exercise therapy, Massed practice

Conventional exercise therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, who upon initial testing, demonstrate partial or complete denervation (loss of nerve supply) of the nerves to the the targeted muscle.

Sponsors & Collaborators

• University of Alberta: lead
• International Spinal Research Trust: collaborator
• Alberta Heritage Foundation for Medical Research: collaborator

Study Sites (1)

Centre for Neuroscience, University of Alberta

Edmonton, Alberta, T6C1M8, Canada

Location

Related Publications (1)

• 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.

  PMID: 21372246 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Arthur Prochazka

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 10, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

CA (1)