Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462449
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2007-04-17
Brief Title:
Efficacy of Functional Electrical Stimulation FES in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Single Blind Randomized Study to Determine the Safety and the Efficacy of Using Functional Electrical Stimulation FES and Repetitive Task Practice vs Repetitive Task Practice Alone in Persons Receiving Botulinum Neurotoxin Type A Injections for Upper Extremity Spasticity
Status:
COMPLETED
Status Verified Date:
2014-06
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:
Botox FES
Brief Summary:
FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord Small electrical impulses are used to excitestimulate the nerves that supply paralyzed muscles This activates those muscles enabling them to produce basic but useful movement Self-adhesive patches electrodes are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses In this way FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord
Repetitive task practice is an activity-based therapy program that has been shown to enhance the recovery of hand and arm functions after stroke This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand These activities are designed to stimulate functional improvement with repetitive practice
Spasticity is a nervous system disorder where certain muscles are continuously contracted Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation FES to help improve muscle function after stroke
Repetitive task practice is an activity-based therapy program that has been shown to enhance the recovery of hand and arm functions after stroke This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand These activities are designed to stimulate functional improvement with repetitive practice
Spasticity is a nervous system disorder where certain muscles are continuously contracted Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation FES to help improve muscle function after stroke
Detailed Description:
This is a single-blinded randomized controlled trial examining the effect of repetitive task practice RTP and functional electrical stimulation FES in individuals who receive routine clinical Botox injections for upper extremity spasticity Botox injections in combination with repetitive task practice RTP is used routinely to manage upper limb spasticity after stroke or acquired brain injury RTP is an activity-based rehabilitation program that has been shown effective in promoting motor recovery Wolf et al 2002 but it requires a sufficient level of baseline motor function Since FES enhances motor function we hypothesize that an FES-assisted RTP intervention will provide greater improvement in hand function than RTP alone in patients receiving Botox injections
The primary outcome will be upper extremity use during activities of daily living assessed observationally by the motor activities log MAL-O Secondary outcomes will be 1 dexterous hand function as measured by the action research arm test ARAT 2 clients perception of self-performance in activities of daily living assessed with the MAL - Self Report 3 global upper extremity impairment assessed by the Chedoke-McMaster Assessment CMA and 4 clinical spasticity assessed by the Modified Ashworth Scale MAS
The primary endpoint will be 6 weeks post-injection Outcomes will also be assessed at a secondary endpoint 12 weeks post-injection to determine the persistence of treatment effects
The primary outcome will be upper extremity use during activities of daily living assessed observationally by the motor activities log MAL-O Secondary outcomes will be 1 dexterous hand function as measured by the action research arm test ARAT 2 clients perception of self-performance in activities of daily living assessed with the MAL - Self Report 3 global upper extremity impairment assessed by the Chedoke-McMaster Assessment CMA and 4 clinical spasticity assessed by the Modified Ashworth Scale MAS
The primary endpoint will be 6 weeks post-injection Outcomes will also be assessed at a secondary endpoint 12 weeks post-injection to determine the persistence of treatment effects
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