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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to Investigate the feasibility of a high-quality, high-dose, high-intensity upper extremity therapy program and to assess the treatment effects of a high-quality, high-dose, high-intensity upper extremity therapy program on functional outcomes, motor impairment, and quality of life

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 data supports the effectiveness of the SUPER Program treatment for stroke recovery?

Research shows that intensive therapy programs, like the SUPER Program, can improve upper limb function after a stroke. For example, Action Observation Therapy (AOT) has been found to enhance motor recovery in stroke patients, suggesting that similar intensive treatments may be effective. ^{1 2 3 4 5}

Is intensive upper limb therapy for stroke generally safe for humans?

The studies reviewed, including those on Constraint-Induced Movement Therapy and Action Observation Therapy, report improvements in motor recovery for stroke patients without mentioning any adverse events, suggesting these therapies are generally safe. ^{1 3 4 6 7}

How is the SUPER Program treatment different from other stroke treatments?

The SUPER Program is unique because it focuses on intensive, high-repetition task-specific training for the upper limb, which is designed to improve arm function after a stroke. This approach is more intensive than standard therapies and aims to optimize recovery by increasing the amount and intensity of therapy early on. ^{1 5 8 9 10}

Research Team

Sean Savitz

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

I have been diagnosed with advanced dementia.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? [2017]

2. Sweden pubmed.ncbi.nlm.nih.gov

Evaluation of a technology-assisted enriched environmental activities programme for upper limb function: A randomized controlled trial. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. [2023]

4. United States 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. [2022]

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

Multicenter randomized trial of robot-assisted rehabilitation for chronic stroke: methods and entry characteristics for VA ROBOTICS. [2022]

6. United States 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. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in stroke patients: systematic review and meta-analysis. [2018]

8. England 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. [2022]

9. United States 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. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Is there a dose-dependent effect of modified constraint-induced movement therapy in patients with hemiplegia? [2019]