Trial Outcomes & Findings for Patient Targeted Upper Extremity Rehabilitation After Stroke (NCT NCT01819506)

NCT ID: NCT01819506

Last Updated: 2019-08-08

Results Overview

The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is traditionally scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Instead of this traditional scoring method, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability.

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

Results posted on

2019-08-08

Participant Flow

Recruited from a University Stroke Rehabilitation Research Registry.

Participant milestones

Participant milestones
Measure	MATCH MATCH is defined as a task-practice occupational therapy program targeting patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care Usual Care is defined as a non-targeted task practice standard of care occupational therapy program consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.
Overall Study STARTED	51	52
Overall Study COMPLETED	43	47
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MATCH MATCH is defined as a task-practice occupational therapy program targeting patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care Usual Care is defined as a non-targeted task practice standard of care occupational therapy program consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.
Overall Study Physician Decision	5	2
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Patient Targeted Upper Extremity Rehabilitation After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MATCH Targeted Task Practice n=51 Participants Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care: Non-Targeted Task Practice n=52 Participants Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Total n=103 Participants Total of all reporting groups
Age, Continuous	55.47 years STANDARD_DEVIATION 12.61 • n=5 Participants	57.58 years STANDARD_DEVIATION 13.09 • n=7 Participants	55.53 years STANDARD_DEVIATION 12.83 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	51 Participants n=5 Participants	52 Participants n=7 Participants	103 Participants n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

Outcome measures

Outcome measures
Measure	MATCH Targeted Task Practice n=51 Participants Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care: Non-Targeted Task Practice n=52 Participants Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.
Fugl-Meyer Assessment of the Upper Extremity	4.08 score on a scale Standard Deviation 4.39	2.45 score on a scale Standard Deviation 4.34

PRIMARY outcome

Timeframe: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function.

Outcome measures

Outcome measures
Measure	MATCH Targeted Task Practice n=51 Participants Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care: Non-Targeted Task Practice n=52 Participants Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.
Wolf Motor Function Test	-4.81 seconds Standard Deviation 8.40	-6.51 seconds Standard Deviation 18.85

SECONDARY outcome

Timeframe: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

Population: Complete and accurate data for this measure is no longer available.

sEMG analysis is an objective method to study muscle coordination during functional arm movements. Subjects will be fitted with sensors on the skin placed over 8 arm/shoulder muscles on both arms. The sensors will detect the muscle activity of these muscles during functional reaching movements. sEMG data will be recorded with a 16-channel wireless Motion Labs EMG system and processed with custom ORBIS software.

Outcome measures

Outcome data not reported

Adverse Events

MATCH Targeted Task Practice

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Usual Care: Non-Targeted Task Practice

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MATCH Targeted Task Practice n=51 participants at risk Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care: Non-Targeted Task Practice n=52 participants at risk Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.
Vascular disorders subsequent stroke	2.0% 1/51 • Number of events 1 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.	1.9% 1/52 • Number of events 1 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.

Other adverse events

Other adverse events
Measure	MATCH Targeted Task Practice n=51 participants at risk Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.	Usual Care: Non-Targeted Task Practice n=52 participants at risk Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy.
Skin and subcutaneous tissue disorders Fall	2.0% 1/51 • Number of events 1 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.	0.00% 0/52 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.
Gastrointestinal disorders sick	5.9% 3/51 • Number of events 3 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.	0.00% 0/52 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.
Ear and labyrinth disorders vertigo	0.00% 0/51 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.	1.9% 1/52 • Number of events 1 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.
Cardiac disorders cardiac problems	2.0% 1/51 • Number of events 1 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.	0.00% 0/52 • An expected average of 4 weeks All-cause Mortality was not monitored/addressed.

Additional Information

Michelle Woodbury

Ralph H Johnson VAMC

Phone: 843-792-1671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place