intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)

NCT ID: NCT05689502

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Treatment

Intervention Type DEVICE

Subjects will participate in 6 hours of therapy a day, 5 days a week, for 3 consecutive weeks. These sessions will include 2 hours of occupational therapy, 2 hours of physical therapy, and 2 hours of guided individual work. Some of these sessions will be in a group setting. The therapy sessions will be individualized to the subject's personal goals and will focus on improving the function of the arm most affected by the stroke. Sessions may include electrical stimulation of the muscles, if it is determined to be safe. At the end of each week, the therapists will recommend exercises for the subjects to continue to work on at home on the weekend.

Interventions

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Treatment

Subjects will participate in 6 hours of therapy a day, 5 days a week, for 3 consecutive weeks. These sessions will include 2 hours of occupational therapy, 2 hours of physical therapy, and 2 hours of guided individual work. Some of these sessions will be in a group setting. The therapy sessions will be individualized to the subject's personal goals and will focus on improving the function of the arm most affected by the stroke. Sessions may include electrical stimulation of the muscles, if it is determined to be safe. At the end of each week, the therapists will recommend exercises for the subjects to continue to work on at home on the weekend.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Single qualifying stroke event as confirmed by CT or MRI
* At least 6 months post stroke
* Fugl-Meyer upper extremity (UE) score of 20-45
* Able to follow written instructions
* Able to tolerate 6 hours of therapy a day

Exclusion Criteria

* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
* Active drug or alcohol abuse
* Diagnosed with advanced dementia
* Pre-stroke baseline mRS\>3
* History of clinically significant ischemic or hemorrhagic stroke resulting in prior arm weakness in the same territory as the index stroke
* Medical instability assessed by the treating stroke physician to participate to the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sean Savitz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Savitz

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-22-0774

Identifier Type: -

Identifier Source: org_study_id

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