NCT01819506: TARG

Patient Targeted Upper Extremity Rehabilitation After Stroke

Completed NA Results posted Last updated 8 August 2019

What this trial tests

NA trial testing Task Practice Physical Rehabilitation Therapy in Stroke in 103 participants. Completed in 31 March 2017.

Timeline

1 March 2013

Primary endpoint
31 March 2017

31 March 2017

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	103
Start date	1 March 2013
Primary completion	31 March 2017
Estimated completion	31 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Task Practice Physical Rehabilitation Therapy

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 89, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fugl-Meyer Assessment of the Upper Extremity Primary · participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

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.

Group	Value	95% CI
MATCH Targeted Task Practice	4.08	± 4.39
Usual Care: Non-Targeted Task Practice	2.45	± 4.34

Wolf Motor Function Test Primary · 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.

Group	Value	95% CI
MATCH Targeted Task Practice	-4.81	± 8.40
Usual Care: Non-Targeted Task Practice	-6.51	± 18.85

Adverse events — posted to ClinicalTrials.gov

Time frame: An expected average of 4 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MATCH Targeted Task Practice

Serious: 1/51 (2%)

Deaths: 0

Usual Care: Non-Targeted Task Practice

Serious: 1/52 (2%)

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	MATCH Targeted Task Practice	Usual Care: Non-Targeted T…
subsequent stroke	Vascular disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	MATCH Targeted Task Practice	Usual Care: Non-Targeted T…
sick	Gastrointestinal disorders	—	—
Fall	Skin and subcutaneous tissue disorders	—	—
vertigo	Ear and labyrinth disorders	—	—
cardiac problems	Cardiac disorders	—	—

Most-reported serious reactions: subsequent stroke.

Data from ClinicalTrials.gov NCT01819506 adverse events section.

Sponsor's own description

Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development of a Short Form Assessment Combining the Fugl-Meyer Assessment-Upper Extremity and the Wolf Motor Function Test for Evaluating Stroke Recovery.
   Woodbury M, Grattan ES, Li CY. · · 2023 · cited 5× · PMID 37245692 · DOI 10.1016/j.apmr.2023.04.029