NCT01819506

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 6, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4.1 years

First QC Date

March 11, 2013

Results QC Date

August 17, 2018

Last Update Submit

August 5, 2019

Conditions

Stroke

Keywords

rehabilitationoccupational therapyupper extremity

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment of the Upper Extremity

    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.

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

  • Wolf Motor Function Test

    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.

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

Secondary Outcomes (1)

  • Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations

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

Study Arms (2)

Targeted Task Practice

EXPERIMENTAL

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. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length.

Behavioral: Task Practice Physical Rehabilitation Therapy

Non-Targeted Task Practice

ACTIVE COMPARATOR

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. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length.

Behavioral: Task Practice Physical Rehabilitation Therapy

Interventions

Task Practice Physical Rehabilitation TherapyBEHAVIORAL

Similar to stroke rehabilitation occupational therapy.

Also known as: Task Practice
Non-Targeted Task PracticeTargeted Task Practice

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals are eligible for this study if they have:
  • experienced a stroke at least 3 months prior that has resulted in unilateral hemiparesis.
  • exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
  • impairment with overhead reach and wrist circumduction and fine motor dexterity.
  • passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

You may not qualify if:

  • Individuals are not eligible for this study if they have:
  • a lesion in the brainstem or cerebellum.
  • another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
  • pain in the affected upper extremity that would limit participation in the study intervention.
  • difficulty understanding and following 3-step directions.
  • difficulty sitting independently without postural support.
  • an orthopedic condition or impaired corrected vision that alters the kinematics of reaching.
  • are unable to travel to and remain in Charleston SC for the duration of the 4-week study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (2)

  • Woodbury ML, Velozo CA, Richards LG, Duncan PW, Studenski S, Lai SM. Dimensionality and construct validity of the Fugl-Meyer Assessment of the upper extremity. Arch Phys Med Rehabil. 2007 Jun;88(6):715-23. doi: 10.1016/j.apmr.2007.02.036.

    PMID: 17532892BACKGROUND

  • Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.

    PMID: 22234665BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Michelle Woodbury
Organization
Ralph H Johnson VAMC
Woodbuml@musc.edu
843-792-1671

Study Officials

  • Michelle L. Woodbury, PhD

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

August 8, 2019

Results First Posted

June 6, 2019

Record last verified: 2019-08

Locations

US(1)