StrokeNCT04050150
Arm Training in Standing After Stroke
A study testing Arm training in standing in people with Stroke, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Arm training in standing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Arm training in standing
- Keywords
- Rehabilitation, Upper Extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm training in standingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Arm Training in Standing | Experimental | Task-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention. Receives: Behavioral: Arm training in standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sessions Completed
Total number of treatment sessions completed
Measured: 8 weeks
Fatigue
Mean change in self-reported fatigue from the start to the end of each intervention session
Measured: 8 weeks
Treatment intensity
Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking
Measured: 8 weeks
Action Research Arm Test
Clinical measure of arm and hand function
Measured: Change from Baseline to 8 weeks
Arm Use Measured with Accelerometers
Arm use measured during a typical day using accelerometers worn on the wrist
Measured: Change from Baseline to 8 weeks
Secondary outcomes (6)
Upper Extremity Fugl-Meyer
Clinical Measure of arm and hand impairment
Measured: Change from Baseline to 8 weeks
Box & Blocks Test
Clinical measure of hand function
Measured: Change from Baseline to 8 weeks
Nine-Hole Peg Test
Clinical measure of hand dexterity
Measured: Change from Baseline to 8 weeks
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.
Measured: Change from Baseline to 8 weeks
Timed Up and Go
Clinical measure of mobility and balance
Measured: Change from Baseline to 8 weeks
Activities Specific Balance Confidence Scale
Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better
Measured: Change from Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start31 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Stewart, PT, PhD, University of South Carolina
- Investigators
- Jll Stewart, PT, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050150
- Sponsor's protocol ID
- Pro00080332
- Status last verified
- Jan 2022
- First submitted
- 6 Aug 2019
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available per reasonable request to the principal investigator 1 year after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT04050150
- Acronym / sponsor ID
- Pro00080332
- Conditions
- Stroke
- Keywords
- Rehabilitation, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Training in Standing | Experimental | Behavioral: Arm training in standingTask-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm training in standingArm 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. | Behavioural | Arm Training in Standing |
Primary outcome
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
6 secondary outcomes
Upper Extremity Fugl-Meyer
Time frame: Change from Baseline to 8 weeks
Box & Blocks Test
Time frame: Change from Baseline to 8 weeks
Nine-Hole Peg Test
Time frame: Change from Baseline to 8 weeks
Stroke Impact Scale Hand Domain Subscale
Time frame: Change from Baseline to 8 weeks
Timed Up and Go
Time frame: Change from Baseline to 8 weeks
Activities Specific Balance Confidence Scale
Time frame: Change from Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: Yes. De-identified data will be made available per reasonable request to the principal investigator 1 year after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jll Stewart, PT, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm training in standing in people with Stroke, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sessions Completed (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.