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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different practice conditions might help stroke survivors improve the use of their weaker arm. Participants will split into two groups to practice a simple motor task, such as scooping beans with a spoon, over two days. One group will experience a special practice element revealed later. The trial aims to determine which practice method better supports learning and retaining new skills. It is suitable for those who had a stroke over six months ago, have arm weakness, and can follow simple instructions. As an unphased study, this trial offers participants the chance to contribute to innovative research that could enhance rehabilitation techniques for stroke survivors.

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.

What prior data suggests that this protocol is safe for stroke survivors?

Research shows that specific safety information for using motor task practice to help stroke survivors improve arm use is lacking. This means clear evidence about its safety in humans is unavailable. However, motor task practice, a type of rehabilitation exercise, is generally well-tolerated by patients.

Similar studies involving task-oriented training have observed improvements in motor control and daily activities, suggesting these exercises usually don't cause harm. While this doesn't provide direct safety evidence, it indicates that similar therapies are generally safe. Participants in these studies often report positive results without significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Motor Task Practice for Hemiparesis trial because it explores how different practice strategies might enhance rehabilitation for individuals with hemiparesis, a condition often resulting from a stroke that causes weakness on one side of the body. Unlike traditional therapies that might focus on repetitive exercises without variation, this trial investigates the impact of incorporating a specific practice variable into motor training. The goal is to uncover whether varying practice conditions can lead to more effective motor learning and faster recovery times. By comparing training with and without this practice variable, the trial could reveal new insights into optimizing rehabilitation exercises, potentially leading to more personalized and effective treatment plans for patients.

What evidence suggests that this trial's treatments could be effective for hemiparesis?

Research has shown that varying practice routines can significantly enhance motor skill learning. One study found that people who practiced in diverse ways retained task performance better, even after a break. Additionally, repeated practice of specific tasks has helped stroke survivors improve movement control, facilitating everyday activities. In this trial, participants will be divided into two groups: one will train with a practice variable, while the other will train without it. Adding variety to practice sessions may lead to better recovery for those with hemiparesis, a condition where one side of the body is weaker or less coordinated. These findings support the idea that varying practice conditions could aid stroke survivors in regaining arm function. ^{2 5 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5120477/

Effects of variable practice on the motor learning outcomes ... The purpose of this study was to determine the influence of variable practice on the motor learning outcomes of wheelchair propulsion in able- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7572736/

The Efficiency, Efficacy, and Retention of Task Practice in ... In motor skill learning, larger doses of practice lead to greater efficacy of practice, lower efficiency of practice, and better long-term retention.

3. withpower.com withpower.com/trial/phase-paresis-2-2023-56838

Motor Task Practice for Hemiparesis · Info for Participants 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 ...

4. researchgate.net researchgate.net/publication/395026058_Effectiveness_of_Task-Oriented_Training_in_Improving_Motor_Function_in_Post-Stroke_Hemiplegia_A_Systematic_Review

(PDF) Effectiveness of Task-Oriented Training in Improving ... Outcomes included motor function, mobility, and activities of daily living. The results shows that, TOT significantly improved motor control, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1836955318301152

Interventions involving repetitive practice improve strength ... The primary outcome was voluntary strength in muscles trained as part of the intervention. The secondary outcomes were measures of lower limb and upper limb ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5020059/

Rehabilitation of Motor Function after Stroke - PubMed Central This multiple systematic review focuses both on standard treatment methods and on innovating rehabilitation techniques used to promote upper extremity motor ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7329565/

Task-specific vs impairment-based training on locomotor ... The purpose of this blinded-assessor randomized trial was to evaluate the effects of task-specific vs impairment-based interventions on walking outcomes in ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.118.022157

Dual-Task Exercise Reduces Cognitive-Motor Interference ... The dual-task program was effective in improving dual-task mobility, reducing falls and fall-related injuries in ambulatory chronic stroke patients with intact ...