Clinical trial NCT04050150: Arm Training in Standing After Stroke
Official title: Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Upper Extremity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sessions Completed
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
measure: Treatment intensity
timeFrame: 8 weeks
measure: Action Research Arm Test
timeFrame: Change from Baseline to 8 weeks
measure: Arm Use Measured with Accelerometers
timeFrame: Change from Baseline to 8 weeks
Secondary outcomes:
measure: Upper Extremity Fugl-Meyer
timeFrame: Change from Baseline to 8 weeks
measure: Box & Blocks Test
timeFrame: Change from Baseline to 8 weeks
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline to 8 weeks
measure: Stroke Impact Scale Hand Domain Subscale
timeFrame: Change from Baseline to 8 weeks
measure: Timed Up and Go
timeFrame: Change from Baseline to 8 weeks
measure: Activities Specific Balance Confidence Scale
timeFrame: Change from Baseline to 8 weeks
Other outcomes:
measure: Berg Balance Scale
timeFrame: Change from Baseline to 8 weeks
measure: Functional Gait Assessment
timeFrame: Change from Baseline to 8 weeks
measure: Stroke Impact Scale Mobility Subscale
timeFrame: Change from Baseline to 8 weeks
measure: Action Research Arm Test
timeFrame: Change from Baseline to 12 weeks
measure: Arm Use Measured with Accelerometers
timeFrame: Change from Baseline to 12 weeks
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Jll Stewart, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: