Motor Task Practice for Hemiparesis

Overseen By Dawn Nilsen, EdD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Botox

Disqualifiers: Severe neglect, Arm pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to learn about practice conditions that may benefit stroke survivors when learning to use their more affected arm to perform a task. Participants will be randomized into two groups. Experimental and control groups will differ by one practice variable that will not be disclosed until completion of testing procedures. Participants will practice a motor task using both their more and less affected arms for two consecutive days. A Pre-Test will be administered on Day 1 before the training begins. Immediate Transfer of Learning will be administered on Day 2 after the completion of training. Delayed (24-hour) Retention and Transfer Tests will be administered on Day 3.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is motor task practice for hemiparesis safe for humans?

The studies reviewed do not provide specific safety data for motor task practice in humans, but they do not report any adverse effects, suggesting it may be generally safe. ^{1 2 3 4 5}

How does the treatment 'Motor Task Practice for Hemiparesis' differ from other treatments for hemiparesis?

This treatment is unique because it focuses on task-specific motor learning, which can stimulate neuroplastic changes in the brain, helping to reorganize and improve motor function after a stroke. Unlike general arm use, task-specific practice has been shown to facilitate motor learning and alter brain activity patterns, potentially leading to better recovery outcomes. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment No Practice Variable, Practice Variable for hemiparesis?

Research shows that repetitive task-specific practice, especially when combined with electrical stimulation and behavioral supports, can significantly reduce impairment in stroke survivors with moderate upper extremity deficits. This suggests that practice-based treatments may be effective for improving motor function in individuals with hemiparesis. ^{5 6 10 11 12}

Who Is on the Research Team?

Dawn Nilsen, EdD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for stroke survivors with upper limb weakness who can follow commands and have had a stroke at least 6 months ago. They should be able to speak English, have not received Botox in the last 3 months, and not currently be in upper limb therapy. Severe neglect or arm pain that limits movement disqualifies participation.

Inclusion Criteria

It has been over 6 months since my stroke.

My Box and Block test score is between 3 and 60.

I can understand and follow simple instructions.

Exclusion Criteria

I am unable to understand and agree to the study's details on my own.

I have arm pain that stops me from moving it normally.

I have received Botox in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Test

A Pre-Test is administered on Day 1 before the training begins

1 day

1 visit (in-person)

Training

Participants practice a motor task using both their more and less affected arms for two consecutive days

2 days

2 visits (in-person)

Immediate Transfer Test

Immediate Transfer of Learning is administered on Day 2 after the completion of training

1 day

1 visit (in-person)

Follow-up

Delayed (24-hour) Retention and Transfer Tests are administered on Day 3

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• No Practice Variable
• Practice Variable

Trial Overview The study tests how different practice conditions affect learning to use the affected arm after a stroke. Participants are divided into two groups by chance; one group will receive an undisclosed practice variable during training. The effectiveness of these methods is measured over three days.

How Is the Trial Designed?

Group I: Training without Practice Variable Experimental Treatment 1 Intervention

All participants will practice a motor task (the Scooping Task) for 2 consecutive days. Each day of training, participants will complete 50 trials (10 blocks of 5 trials each) with their more affected arm and 20 trials (10 blocks of 2 trials each) with their less affected arm. One trial of the task will involve using a spoon to scoop beans, one at a time, from one cup to another while seated at a table. Participants will be asked to complete as many scoops as possible from the cup closest to them to the cup farthest from them within 30 seconds in an anterior-posterior direction. One successful repetition occurs when at least one bean is transferred. The number of successful repetitions within a 30 second trial is then counted. Training for the control group will not include the practice variable of interest.

Group II: Training with Practice Variable Experimental Treatment 1 Intervention

All participants will practice a motor task (the Scooping Task) for 2 consecutive days. Each day of training, participants will complete 50 trials (10 blocks of 5 trials each) with their more affected arm and 20 trials (10 blocks of 2 trials each) with their less affected arm. One trial of the task will involve using a spoon to scoop beans, one at a time, from one cup to another while seated at a table. Participants will be asked to complete as many scoops as possible from the cup closest to them to the cup farthest from them within 30 seconds in an anterior-posterior direction. One successful repetition occurs when at least one bean is transferred. The number of successful repetitions within a 30 second trial is then counted. Training for the experimental group will include the practice variable of interest.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a study involving 9 chronic stroke survivors, a combination of repetitive task-specific practice (RTP) with electrical stimulation and behavioral supports led to significant improvements in upper extremity function and dexterity over an 8-week period.

Participants showed marked increases in their ability to use their affected arm for daily activities, indicating that this intervention not only improved physical capabilities but also enhanced their quality of life by enabling them to perform valued tasks they had previously been unable to do.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Reps" Aren't Enough: Augmenting Functional Electrical Stimulation With Behavioral Supports Significantly Reduces Impairment in Moderately Impaired Stroke. Page, SJ., Levine, PG., Basobas, BA.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Chronicity of Stroke Does Not Affect Outcomes of Somatosensory Stimulation Paired With Task-Oriented Motor Training: A Secondary Analysis of a Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The efficacy of combined physical and mental practice in the learning of a foot-sequence task after stroke: a case report. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

"Reps" Aren't Enough: Augmenting Functional Electrical Stimulation With Behavioral Supports Significantly Reduces Impairment in Moderately Impaired Stroke. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Stroke motor recovery: active neuromuscular stimulation and repetitive practice schedules. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Reliability and responsiveness of elbow trajectory tracking in chronic poststroke hemiparesis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Test-retest reliability in performance of persons with hemiparesis tracking by means of compatibly displayed myoelectric feedback derived from upper limb muscles. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The effect of foot position and chair height on the asymmetry of vertical forces during sit-to-stand and stand-to-sit tasks in individuals with hemiparesis. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Robotic/virtual reality intervention program individualized to meet the specific sensorimotor impairments of an individual patient: a case study. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Hemiparetic stroke impairs anticipatory control of arm movement. [2018]

10. Ireland pubmed.ncbi.nlm.nih.gov

Motor learning after stroke: is skill acquisition a prerequisite for contralesional neuroplastic change? [2016]

11. England pubmed.ncbi.nlm.nih.gov

Precise isometric hand grip learning of hemiparetic stroke patients. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Integrated versus isolated training of the hemiparetic upper extremity in haptically rendered virtual environments. [2021]