Overview

This trial is active, not recruiting.

Conditions spinal cord injury, quadriplegia, tetraplegia
Treatments fes-assisted in-home telerehabilitation of hand function, exercise training
Phase phase 2/phase 3
Sponsor University of Alberta
Collaborator International Spinal Research Trust
Start date May 2007
End date December 2011
Trial size 20 participants
Trial identifier NCT00656149, ISRT-G700000249 PY107, SCI-IHT

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
FES-assisted hand exercises on a workstation.
fes-assisted in-home telerehabilitation of hand function In-home telerehabilitation
6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
(Active Comparator)
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).
exercise training In-home telerehabilitation
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 Outcomes

Measure
Action Research Arm Test
time frame: every 2 weeks during therapy

Secondary Outcomes

Measure
Transcranial magnetic stimulation
time frame: every 2 weeks during therapy

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Outcome Evaluation of Exercise and Electrical Therapy for Quadriplegic Hand Function
Principal investigator Arthur Prochazka
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by University of Alberta.