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Arm Training in Standing After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050150
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jill Stewart, PT, PhD, University of South Carolina

Tracking Information
First Submitted Date  ICMJE August 6, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date August 8, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Sessions Completed [ Time Frame: 8 weeks ]
    Total number of treatment sessions completed
  • Fatigue [ Time Frame: 8 weeks ]
    Mean change in self-reported fatigue from the start to the end of each intervention session
  • Treatment intensity [ Time Frame: 8 weeks ]
    Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking
  • Action Research Arm Test [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of arm and hand function
  • Arm Use Measured with Accelerometers [ Time Frame: Change from Baseline to 8 weeks ]
    Arm use measured during a typical day using accelerometers worn on the wrist
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Upper Extremity Fugl-Meyer [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical Measure of arm and hand impairment
  • Box & Blocks Test [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of hand function
  • Nine-Hole Peg Test [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of hand dexterity
  • Stroke Impact Scale Hand Domain Subscale [ Time Frame: Change from Baseline to 8 weeks ]
    Patient-reported measure of hand related quality-of-life. Score ranges from 0 to 100 with higher being better.
  • Timed Up and Go [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of mobility and balance
  • Activities Specific Balance Confidence Scale [ Time Frame: Change from Baseline to 8 weeks ]
    Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2019)
  • Berg Balance Scale [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of balance. 14-item performance measure with a maximum score of 56; higher score is better.
  • Functional Gait Assessment [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of balance
  • Stroke Impact Scale Mobility Subscale [ Time Frame: Change from Baseline to 8 weeks ]
    Patient-reported measure of mobility related quality-of-life. Score ranges from 0 to 100 with higher being better
  • Action Research Arm Test [ Time Frame: Change from Baseline to 12 weeks ]
    Clinical measure of arm and hand function
  • Arm Use Measured with Accelerometers [ Time Frame: Change from Baseline to 12 weeks ]
    Arm use measured during a typical day using accelerometers worn on the wrist
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Arm Training in Standing After Stroke
Official Title  ICMJE Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study
Brief Summary This study will examine the feasibility of providing task-oriented arm training in standing or during walking in individuals with movement deficits due to stroke. Participants will received 24 sessions of arm training in standing over an 8-week period that focus on arm and hand function.
Detailed Description

Residual motor deficits are common after stroke and often have a negative impact on the performance of functional activities and overall quality of life. A frequently reported contribution to these functional limitations is an inability to incorporate the weaker arm and hand into daily activities. While rehabilitation interventions can improve arm functional capacity, these improvements often do not translate into increased real-world arm use which is often reduced after stroke.

The performance of skilled arm and hand movements in standing requires precise coordination between upper extremity movement and balance control. Many everyday functional tasks that require the arm are performed in standing (e.g. opening a door or meal preparation at the kitchen counter), however, training of arm function in rehabilitation is often done in sitting. An important rehabilitation approach may be to create a training environment that resembles the way the arm is used in everyday life (i.e. standing). This study will examine the feasibility of providing task-oriented, functional arm training in standing and during walking in individuals with motor deficits due to stroke.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: Arm training in standing
Arm training will be provided in one hour sessions, 3 time per week for 8 weeks. In each session, you will practice functional tasks with your weaker arm and hand in standing or during walking. Practice will be scaled to match your current level of function and progressed over time as able.
Study Arms  ICMJE Experimental: Arm Training in Standing
Task-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention.
Intervention: Behavioral: Arm training in standing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old
  • Had a stroke at least 6 months prior to enrollment
  • Show evidence of continued arm and hand weakness
  • Have some ability to move the arm and hand that is weaker from the stroke
  • Be able to stand with minimal assistance or less without support of the weaker arm for at least 2 minutes
  • Be able to follow two-step commands.

Exclusion Criteria:

  • Acute medical issues that would interfere with participation
  • Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
  • Severe apraxia or hemispatial neglect
  • Pain that interferes with arm movement or standing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill Stewart, PT, PhD 803-777-6583 jcstewar@mailbox.sc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04050150
Other Study ID Numbers  ICMJE Pro00080332
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available per reasonable request to the principal investigator 1 year after study completion.
Time Frame: 1 year after study completion
Responsible Party Jill Stewart, PT, PhD, University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jll Stewart, PT, PhD University of South Carolina
PRS Account University of South Carolina
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP