NCT02882997

Brief Summary

This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Nov 2013

Typical duration for phase_1 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

August 5, 2016

Last Update Submit

August 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Paretic arm use

    The amount of paretic arm use will be measured by wrist worn accelerometers. Subjects will be shown how to don/doff wristwatch sized triaxial Actigraph accelerometers (GT3X+ Activity Monitor; ActiGraph LLC) by securing a Velcro band on the dorsal aspect of each wrist proximal to the wrist joint. Subjects will be instructed to don the accelerometers each time they engaged in either the computer game or standard activity and wear them only for the duration of the activity. The accelerometers will be stored in a box during other times. Accelerometry data will be recorded in 1 minute epochs as the number of arm activity counts. At the final study evaluation session, data will be used to create a ratio of paretic to non-paretic arm activity counts. A value of 1 will indicate bilateral arm use, a value higher than 1 will indicate that the paretic arm was used more than the non-paretic arm, and a value less than 1 will indicate that the paretic arm was used less than the non-paretic arm.

    1 year

Secondary Outcomes (3)

  • Fugl Meyer Upper Extremity Assessment

    up to 7 days

  • Wolf Motor Function Test

    up to 7 days

  • Stroke Impact Scale - Hand subtest

    up to 7 days

Study Arms (2)

Duck Duck Punch

EXPERIMENTAL

Community dwelling stroke survivors: Stroke survivors will install an interactive computer game in their home. Subjects will be instructed to play the computer game "as much as you want to every day for 7 days." Inpatient stroke patients: The interactive computer game will be installed at a local inpatient stroke rehabilitation hospital. Subjects will be instructed to "play this game as much as you want to during non-therapy hours (evenings and weekends) over the next 7 days."

Behavioral: an interactive computer game

Standard activities

ACTIVE COMPARATOR

Community dwelling stroke survivors: Subjects will receive a hard-copy handout of an arm home exercise program and given the instructions to "do these exercises as many times as you can daily." Inpatient stroke patients: Subjects will be encouraged to participate in standard evening/weekend recreational activities and to "remember to use the paretic arm as much as you can."

Behavioral: standard activities

Interventions

Duck Duck Punch is an interactive computer game designed to elicit repetitive practice of paretic arm movements in stroke patients.

Duck Duck Punch

For community dwelling stroke survivors this is a hard copy, written/illustrated home exercise program for the paretic arm. For inpatient stroke patients this is standard recreational activities organized by the facility during non therapy hours (evenings and weekends).

Standard activities

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • experienced uni-hemispheric ischemic or hemorrhagic stroke
  • exhibit voluntarily shoulder flexion (affected UE) ≥20° with simultaneous elbow extension ≥10°. We reason that persons at this motor ability level have enough residual arm activation to engage in VE training
  • passive range of motion in affected shoulder and elbow and within 20 degrees of normal values
  • live at home
  • no current rehabilitation therapy
  • live within a 60 minute drive of the university
  • medically stable
  • expected to remain in the hospital for the next 7 days
  • able to sit in a chair for 60 minutes without difficulty

You may not qualify if:

  • lesion in brainstem or cerebellum
  • presence of other neurological disease that may impair motor skills (e.g., Parkinson's Disease)
  • pain in the paretic arm that would interfere with movement
  • unable to understand and follow 3-step directions
  • orthopedic condition or impaired corrected vision that would interfere with reaching.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Woodbury ML, Anderson K, Finetto C, Fortune A, Dellenbach B, Grattan E, Hutchison S. Matching Task Difficulty to Patient Ability During Task Practice Improves Upper Extremity Motor Skill After Stroke: A Proof-of-Concept Study. Arch Phys Med Rehabil. 2016 Nov;97(11):1863-1871. doi: 10.1016/j.apmr.2016.03.022. Epub 2016 Apr 23.

    PMID: 27117385BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michelle L Woodbury, PhD, OTR/L

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 30, 2016

Study Start

November 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations