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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00387673 |
Purpose
Electrical stimulation (pulses of electricity applied over the skin of your wrist) and activity-based hand exercise have been shown to improve motor skill and strength in individuals with stroke and have recently been shown to also have an effect on individuals with spinal cord injury. Therefore, the purpose of this research study is to investigate whether electrical stimulation alone or electrical stimulation followed by activity-based training produces gains in pinch strength (how hard you can squeeze your thumb and pointer finger together) and upper extremity function (how well your arm and hand can perform activities) in individuals with spinal cord injury.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Behavioral: Somatosensory Stimulation and Massed Practice Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI |
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);
|
Behavioral: Somatosensory Stimulation and Massed Practice Training
a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
|
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Active Comparator: 2
a 6-week period of 2 hours somatosensory stimulation of the hand, without training
|
Behavioral: Somatosensory Stimulation and Massed Practice Training
a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
|
|
Placebo Comparator: 3
a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training
|
Behavioral: Somatosensory Stimulation and Massed Practice Training
a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
|
Spinal cord injury (SCI) affects 10,000 individuals per year in the United States. Approximately one half of all individuals with SCI have tetraparesis due to cervical injury. Impaired hand function significantly limits the ability of individuals with cervical SCI to perform manual activities of daily living which affects these individuals physically, psychologically and socially. Preliminary research by this investigator suggests that somatosensory stimulation combined with activity-based training improves hand function and strength in individuals with incomplete cervical SCI. Further investigations on these novel techniques are warranted due to the need to establish proven effective rehabilitation techniques that promote recovery of function in individuals with SCI.
The purpose of this research study is to: 1)determine if somatosensory stimulation in the form of prolonged, peripheral nerve electrical stimulation can enhance the effect of an upper extremity activity-based training program in individuals with incomplete cervical SCI, and if so, 2) identify the operative neural mechanisms underlying the changes induced with the application of somatosensory stimulation.
The hypotheses of this study are that individuals with incomplete cervical SCI:
The specific objectives of this study are to:
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Beekhuizen, Kristina - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00387673 History of Changes |
| Other Study ID Numbers: | B4439Z |
| Study First Received: | October 12, 2006 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Federal Government |
|
electrical stimulation hand Rehabilitation spinal cord injury |
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Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |