Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 11, 2015
September 1, 2014
1.2 years
January 30, 2012
February 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Movement time (MT)
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. MT is the interval between movement onset and offset.
Baseline and change from baseline in MT at 4 weeks
Total displacement (TD)
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand in three-dimensional space and is a measure of trajectory smoothness.
Baseline and change from baseline in TD at 4 weeks
Percentage of peak velocity (PPV)
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. The PPV reflects the duration of the acceleration phase relative to the deceleration phase and indicates the type of movement strategy selected for a motor action.
Baseline and change from baseline in PPV at 4 weeks
Secondary Outcomes (7)
Fugl-Meyer Assessment (FMA)
Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
Medical Research Council scale (MRC)
Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
Modified Ashworth Scale (MAS)
Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
MYOTON-3
Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks
Motor Activity Log (MAL)
Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
- +2 more secondary outcomes
Study Arms (5)
Combined dCIT with FET
EXPERIMENTALCombined distributed constraint induced therapy with functional electrical therapy
Combined BAT with FET
EXPERIMENTALCombined bilateral arm treatment with functional electrical therapy
Control intervention group
ACTIVE COMPARATORControl intervention
dCIT
EXPERIMENTALdistributed constraint induced therapy
BAT
EXPERIMENTALbilateral arm treatment
Interventions
This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities.
The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
The conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks). Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities.
Eligibility Criteria
You may qualify if:
- The onset duration more than 6 months
- An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
- No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
- Considerable nonuse of the affected upper extremity (an AOU score \< 2.5 of Motor Activity Log)
You may not qualify if:
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-yi Wu, ScD
Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 1, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 11, 2015
Record last verified: 2014-09