Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108680
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-04-16
Brief Title:
Effects of Two Different Kinds of Exercise on Stroke Rehabilitation
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Unilateral and Bilateral Training on Motor Function in Chronic Stroke
Status:
COMPLETED
Status Verified Date:
2011-01-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the effectiveness of unilateral versus bilateral exercise training for recovering movement abilities in chronic stroke patients After a stroke some people have improved their movement ability by exercising the arm affected by the stroke Others have improved by exercising both arms together This study will compare these two kinds of exercise to see which might work best
Healthy volunteers and people who have had a stroke more than 6 months ago may be eligible for this study Stroke patients must have some weakness in their stroke-affected arm All participants must be 18 years of age or older Candidates are screened with a clinical and neurological examination Women who can become pregnant have a pregnancy test Stroke patients have a magnetic resonance imaging MRI study of the brain if they have not had one in the last year
Participants undergo the following tests and procedures
MRI This procedure uses a magnetic field and radio waves to produce images of body tissues and organs The subject lies on a table that slides into the scanner a narrow cylinder wearing earplugs to muffle loud knocking sounds that occur during the scanning process The procedure lasts about 45 minutes during which time the subject must lie still for up to 30 minutes
Testing sessions There are six test sessions - two to familiarize the subject with the reaching test two to do the reaching test plus transcranial magnetic stimulation TMS before and after an exercise session and two to do the reaching test plus TMS one day after the exercise session The sessions are on consecutive days with a 1-week break after session 3 The procedures involved are
Reaching test The subject responds as quickly as possible to a GO signal presented on a computer monitor by performing a reaching movement with his or her arm The activity from the arm muscles is recorded using surface electrodes During this test a questionnaire is used to determine the subjects attention fatigue and mood
TMS For this test a wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the arms The subject performs the reaching test while TMS is delivered at various times after getting the GO signal
Arm exercises The subject is seated in front of an exercise device that has two handles that slide forward and backward along a set of tracks The subject is asked to slide either one or both handles back and forth repeatedly alternating 5 minutes of arm exercise with 5 minutes of rest for 30 minutes
Healthy volunteers and people who have had a stroke more than 6 months ago may be eligible for this study Stroke patients must have some weakness in their stroke-affected arm All participants must be 18 years of age or older Candidates are screened with a clinical and neurological examination Women who can become pregnant have a pregnancy test Stroke patients have a magnetic resonance imaging MRI study of the brain if they have not had one in the last year
Participants undergo the following tests and procedures
MRI This procedure uses a magnetic field and radio waves to produce images of body tissues and organs The subject lies on a table that slides into the scanner a narrow cylinder wearing earplugs to muffle loud knocking sounds that occur during the scanning process The procedure lasts about 45 minutes during which time the subject must lie still for up to 30 minutes
Testing sessions There are six test sessions - two to familiarize the subject with the reaching test two to do the reaching test plus transcranial magnetic stimulation TMS before and after an exercise session and two to do the reaching test plus TMS one day after the exercise session The sessions are on consecutive days with a 1-week break after session 3 The procedures involved are
Reaching test The subject responds as quickly as possible to a GO signal presented on a computer monitor by performing a reaching movement with his or her arm The activity from the arm muscles is recorded using surface electrodes During this test a questionnaire is used to determine the subjects attention fatigue and mood
TMS For this test a wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the arms The subject performs the reaching test while TMS is delivered at various times after getting the GO signal
Arm exercises The subject is seated in front of an exercise device that has two handles that slide forward and backward along a set of tracks The subject is asked to slide either one or both handles back and forth repeatedly alternating 5 minutes of arm exercise with 5 minutes of rest for 30 minutes
Detailed Description:
Objective
It has been proposed that individuals with stroke may benefit to a greater degree by training with both arms simultaneously than by training with the paretic arm alone The purpose of this protocol is to identify the extent and the mechanisms of paretic arm performance improvement after a single session of bilateral arm training compared to a single session of unilateral paretic arm training in individuals with moderate-severity chronic stroke
Study population
The study population will consist of individuals with chronic stroke
Design
A single-blinded counterbalanced crossover design will be used
Outcome measures
Endpoint measures will include paretic arm peak acceleration and disinhibition of the stroke-affected cortical hemisphere as measured by transcranial magnetic stimulation TMS in the context of a reaching task These measures will be compared after a unilateral vs a bilateral arm training session in individuals with chronic stroke
It has been proposed that individuals with stroke may benefit to a greater degree by training with both arms simultaneously than by training with the paretic arm alone The purpose of this protocol is to identify the extent and the mechanisms of paretic arm performance improvement after a single session of bilateral arm training compared to a single session of unilateral paretic arm training in individuals with moderate-severity chronic stroke
Study population
The study population will consist of individuals with chronic stroke
Design
A single-blinded counterbalanced crossover design will be used
Outcome measures
Endpoint measures will include paretic arm peak acceleration and disinhibition of the stroke-affected cortical hemisphere as measured by transcranial magnetic stimulation TMS in the context of a reaching task These measures will be compared after a unilateral vs a bilateral arm training session in individuals with chronic stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0142 | None | None | None |