Arm Training in Standing After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050150
• Other study ID #: Pro00080332
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Berg Balance Scale	Clinical measure of balance. 14-item performance measure with a maximum score of 56; higher score is better.	Change from Baseline to 8 weeks
Other	Functional Gait Assessment	Clinical measure of balance	Change from Baseline to 8 weeks
Other	Stroke Impact Scale Mobility Subscale	Patient-reported measure of mobility related quality-of-life. Score ranges from 0 to 100 with higher being better	Change from Baseline to 8 weeks
Other	Action Research Arm Test	Clinical measure of arm and hand function	Change from Baseline to 12 weeks
Other	Arm Use Measured with Accelerometers	Arm use measured during a typical day using accelerometers worn on the wrist	Change from Baseline to 12 weeks
Primary	Sessions Completed	Total number of treatment sessions completed	8 weeks
Primary	Fatigue	Mean change in self-reported fatigue from the start to the end of each intervention session	8 weeks
Primary	Treatment intensity	Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking	8 weeks
Primary	Action Research Arm Test	Clinical measure of arm and hand function	Change from Baseline to 8 weeks
Primary	Arm Use Measured with Accelerometers	Arm use measured during a typical day using accelerometers worn on the wrist	Change from Baseline to 8 weeks
Secondary	Upper Extremity Fugl-Meyer	Clinical Measure of arm and hand impairment	Change from Baseline to 8 weeks
Secondary	Box & Blocks Test	Clinical measure of hand function	Change from Baseline to 8 weeks
Secondary	Nine-Hole Peg Test	Clinical measure of hand dexterity	Change from Baseline to 8 weeks
Secondary	Stroke Impact Scale Hand Domain Subscale	Patient-reported measure of hand related quality-of-life. Score ranges from 0 to 100 with higher being better.	Change from Baseline to 8 weeks
Secondary	Timed Up and Go	Clinical measure of mobility and balance	Change from Baseline to 8 weeks
Secondary	Activities Specific Balance Confidence Scale	Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better	Change from Baseline to 8 weeks