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Completed

NCT Number: NCT04050150

Arm Training in Standing After Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm training in standing

Behavioral

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.

Primary outcomes

  1. Sessions Completed

    Time frame: 8 weeks

    Total number of treatment sessions completed

  2. Fatigue

    Time frame: 8 weeks

    Mean change in self-reported fatigue from the start to the end of each intervention session

  3. Treatment intensity

    Time frame: 8 weeks

    Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking

  4. Action Research Arm Test

    Time frame: Change from Baseline to 8 weeks

    Clinical measure of arm and hand function

  5. 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

Secondary outcomes

  1. Upper Extremity Fugl-Meyer

    Time frame: Change from Baseline to 8 weeks

    Clinical Measure of arm and hand impairment

  2. Box & Blocks Test

    Time frame: Change from Baseline to 8 weeks

    Clinical measure of hand function

  3. Nine-Hole Peg Test

    Time frame: Change from Baseline to 8 weeks

    Clinical measure of hand dexterity

  4. 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.

  5. Timed Up and Go

    Time frame: Change from Baseline to 8 weeks

    Clinical measure of mobility and balance

  6. 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

Other outcomes

  1. 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.

  2. Functional Gait Assessment

    Time frame: Change from Baseline to 8 weeks

    Clinical measure of balance

  3. 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

  4. Action Research Arm Test

    Time frame: Change from Baseline to 12 weeks

    Clinical measure of arm and hand function

  5. 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

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2019
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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