Intensive Upper Limb Therapy for Stroke

(SUPER Trial)

Overseen By Emily Stevens, OTR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Advanced dementia, Drug abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an intensive therapy program, the intenSive UpPer Extremity Recovery Program (SUPER Program), can improve arm function and quality of life for stroke survivors. The program emphasizes high-quality, high-dose, and high-intensity therapy for the upper limbs. Participants must have had a single stroke confirmed by a scan, be at least six months post-stroke, and be able to handle six hours of daily therapy. The trial aims to determine if this intensive approach can enhance movement and daily living. As an unphased trial, it offers a unique opportunity to contribute to innovative stroke recovery research and potentially enhance rehabilitation outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the intenSive UpPer Extremity Recovery Program is safe for stroke patients?

Research has shown that intensive upper limb therapy programs are generally safe for stroke survivors. One study reported no harmful effects with a specific type of upper limb therapy, suggesting it is safe and potentially beneficial. Another study tested a similar program and found no significant negative effects, indicating patients tolerated it well. Overall, these findings suggest that the treatment is safe, with no major safety concerns reported to date. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intenSive UpPer Extremity Recovery Program because it offers a fresh approach to rehabilitation after a stroke. Unlike traditional therapies, which often focus on moderate, gradual improvements through standard physical exercises, this program emphasizes intensive, repetitive, and targeted upper limb exercises designed to accelerate recovery. The goal is to harness neuroplasticity—the brain's ability to reorganize itself by forming new neural connections—to improve motor skills more effectively. This method could potentially lead to faster and more significant improvements in arm and hand function for stroke survivors.

What evidence suggests that the intenSive UpPer Extremity Recovery Program might be an effective treatment for stroke?

Research has shown that the Intensive Upper Extremity Recovery Program, which participants in this trial will undergo, can help stroke patients improve arm movement. In one study, patients who participated in this intensive therapy improved by an average of 6 points in arm movement. Another study involved participants using a wearable device to track their progress and receiving support from therapists, which also yielded positive results. However, one trial found that starting therapy too early and with too much intensity did not lead to better outcomes, suggesting that timing and individual differences might be important. Overall, the program has shown promise in helping stroke patients regain arm function. ^{2 3 6 7 8}

Who Is on the Research Team?

Sean Savitz

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

The SUPER trial is for individuals who had a stroke at least 6 months ago, can follow instructions, and handle 6 hours of daily therapy. They should have moderate arm impairment (Fugl-Meyer score of 20-45) confirmed by imaging tests. People with prior significant arm injuries, severe pre-stroke disability, other strokes causing similar symptoms, medical instability, substance abuse issues or advanced dementia cannot participate.

Inclusion Criteria

Your Fugl-Meyer upper extremity (UE) score is between 20 and 45.

I can handle 6 hours of therapy daily.

It has been over 6 months since my stroke.

Exclusion Criteria

You are currently abusing drugs or alcohol.

I have had a stroke before that caused weakness in my arm.

Medical instability assessed by the treating stroke physician to participate to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo a high-quality, high-dose, high-intensity upper extremity therapy program

6 weeks

Multiple sessions per week (in-person)

Follow-up

Participants are monitored for changes in functional outcomes, motor impairment, and quality of life

6 months

Assessments at 1 week, 6 weeks, and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• intenSive UpPer Extremity Recovery Program

Trial Overview

This study tests an intensive upper extremity therapy program designed to improve the function and quality of life in chronic stroke survivors. It focuses on high-quality treatment that's both high-dose and high-intensity to see if it's feasible and effective.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

A study involving 20 stroke survivors identified key factors that influence adherence to intensive upper limb exercise programs, highlighting the importance of routine practice times, accountability to staff, and social support as enablers.

Barriers to adherence included exercises being too difficult, reliance on others for assistance, and challenges in fitting the exercises into daily life, indicating that addressing these issues could improve participation in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Just that four letter word, hope": stroke survivors' perspectives of participation in an intensive upper limb exercise program; a qualitative exploration. Levy, T., J Christie, L., Killington, M., et al.[2022]

The Graded Repetitive Arm Supplementary Program effectively improved upper extremity function and quality of life in stroke survivors, as evidenced by significant gains in various assessments, including the Fugl-Meyer Assessment and Action Research Arm Test.

The program was successfully implemented in a community setting with high participant adherence and ongoing support, demonstrating that partnerships between nonprofit organizations and community centers can facilitate the translation of evidence-based rehabilitation interventions into real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke in a Real World Community Setting: Case Report. Yang, CL., Bird, ML., Eng, JJ.[2022]

A study involving 15 patients with chronic upper-extremity paresis due to stroke demonstrated that high-repetition task-specific training (averaging 322 repetitions per session) is feasible within standard 1-hour therapy sessions, with a high attendance rate of 97%.

Participants showed significant improvements in functional task performance, as indicated by an average increase of 8 points on the Action Research Arm test, which was maintained at a 1-month follow-up, suggesting potential benefits of this intensive training approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Birkenmeier, RL., Prager, EM., Lang, CE.[2022]

In a study of 31 stroke patients undergoing modified constraint-induced movement therapy (mCIMT) for two weeks, all participants showed significant improvements in upper extremity function, as measured by various assessments (P < 0.05).

Despite the overall improvements, the study found no significant correlation between the intensity of rehabilitation (treatment duration or constraining time) and the functional outcomes, suggesting that the effectiveness of mCIMT may not depend on the amount of therapy received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a dose-dependent effect of modified constraint-induced movement therapy in patients with hemiplegia? Lee, HJ., Moon, HI., Kim, JS., et al.[2019]

This phase III randomized controlled trial (RCT) aims to evaluate the effectiveness of constraint-induced therapy (CI therapy) for stroke survivors 3 to 9 months post-stroke, assessing whether the therapy can lead to lasting improvements in motor function over a 2-year period.

The study will analyze how initial motor ability affects responsiveness to CI therapy and whether treatment timing (before 9 months vs. after 1 year) influences outcomes, using both laboratory and real-world measures of function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for a multisite randomized trial to investigate the effect of constraint-induced movement therapy in improving upper extremity function among adults recovering from a cerebrovascular stroke. Winstein, CJ., Miller, JP., Blanton, S., et al.[2022]

The enriched environmental program significantly improved upper limb function in patients compared to the control group, with 83% of participants showing clinically meaningful improvements at discharge.

While both groups showed improvements over time, the enriched environmental group maintained their upper limb function gains better than the control group three months after discharge, indicating the program's lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a technology-assisted enriched environmental activities programme for upper limb function: A randomized controlled trial. Amatya, B., Khan, F., Windle, I., et al.[2020]

Action Observation Training (AOT) significantly improved upper limb motor recovery and functional outcomes in 32 acute stroke patients compared to Task Oriented Training (TOT), with greater gains observed in the Fugl-Meyer Assessment and Functional Independence Measure after 20 sessions over four weeks.

The study found no adverse events associated with AOT, suggesting it is a safe and effective rehabilitative method that should be considered for broader use in subacute stroke patients with upper limb impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. Mancuso, M., Tondo, SD., Costantini, E., et al.[2023]

A randomized controlled trial involving 123 stroke patients found that an early increased-intensity upper limb therapy program did not lead to better outcomes compared to standard care, as measured by the Action Research Arm Test three months post-stroke.

Despite the intervention group receiving more total therapy time (median of 52 minutes/day) than the control group (38 minutes/day), the expected benefits were not realized, likely due to competitive therapy bias affecting the actual therapy received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? Rodgers, H., Mackintosh, J., Price, C., et al.[2017]

The study tested the safety and efficacy of the MIT-Manus robotic device for improving upper extremity function in stroke patients more than 6 months post-stroke, involving 127 participants across three treatment groups: robot-assisted therapy, intensive comparison therapy, and usual care.

The trial, which included participants with a mean age of 65 and primarily ischemic strokes, aimed to measure improvements in motor function using the Fugl-Meyer Assessment, highlighting the potential for robotic therapy in chronic stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized trial of robot-assisted rehabilitation for chronic stroke: methods and entry characteristics for VA ROBOTICS. Lo, AC., Guarino, P., Krebs, HI., et al.[2022]

The updated meta-analysis of 18 studies involving 755 stroke patients found that Constraint-Induced Movement Therapy (CIMT), its modified forms (mCIMT), and Forced Use (FU) no longer show a significant benefit on disability, suggesting that previous findings may have been overestimated.

However, these therapies still demonstrate a moderate benefit on arm motor function, indicating that while they may not reduce disability, they can improve arm movement capabilities in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in stroke patients: systematic review and meta-analysis. Corbetta, D., Sirtori, V., Moja, L., et al.[2018]

Citations

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A Randomized Cross-Over Trial of Intensive Upper-Limb ...

ResultsThirty-nine individuals consented, with 38 completing the program (22 male, age 61.5 ± 14.8 years, 2.8 ± 3.4 years since stroke).

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Intensive Upper Limb Therapy for Stroke (SUPER Trial)

A randomized controlled trial involving 123 stroke patients found that an early increased-intensity upper limb therapy program did not lead to better outcomes ...

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academic.oup.com

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Intensive Upper Extremity Program Coupled With a Wearable ...

The 3-week V-ABC program consisted of exercise, feedback from a wearable device on the use of the paretic upper extremity, and therapist support. Results. Three ...

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ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.124.043650?doi=10.1161/STROKEAHA.124.043650

High-Dose, High-Intensity Stroke Rehabilitation: Why Aren't ...

One recent cohort study of chronic stroke patients who underwent this clinical program showed a median 6-point improvement (interquartile range, ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714421001178

Effectiveness of an intensive, functional, gamified ...

Effectiveness of an intensive, functional, gamified Rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the ...

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pmc.ncbi.nlm.nih.gov

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A Randomized Cross-Over Trial of Intensive Upper-Limb ...

A pragmatic randomized cross-over trial allocated individuals with chronic stroke to Boot Camp or usual care. Boot Camp delivered 90 hours of upper-limb ...

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ahajournals.org

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Long-Term Outcomes of Vagus Nerve Stimulation Paired ...

People treated with paired vagus nerve stimulation maintained improvements in UE impairment, activity, participation, and quality-of-life measures at 1 year.

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jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2488308

Effect of a Task-Oriented Rehabilitation Program on Upper ...

Use of a structured, task-oriented rehabilitation program did not significantly improve motor function or recovery beyond either an equivalent or a lower dose ...