Grade 1 CI Therapy +Sensory Components for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Stroke+3 More
Grade 1 CI Therapy +Sensory Components - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.

Eligible Conditions

  • CVA (Cerebrovascular Accident)
  • Stroke
  • Paresis

Treatment Effectiveness

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: At follow-up at 3 months following the end of treatment.

Month 3
Beck Depression Inventory (BDI)
Month 3
45-Item Motor Activity Log (MAL)
Month 3
Stroke Impact Scale (SIS)
Month 3
Canadian Occupational Performance Measure (COPM)
Week 2
Wolf Motor Function Test (WMFT)
Week 2
9 Hole Peg Test (9HPT)
Revised Nottingham Sensory Assessment (rNSA)
Semmes-Weinstein Monofilament Test (SWMT)

Trial Safety

Trial Design

1 Treatment Group

Grade 1 CI Therapy + Sensory Components
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Grade 1 CI Therapy +Sensory Components · No Placebo Group · N/A

Grade 1 CI Therapy + Sensory Components
Behavioral
Experimental Group · 1 Intervention: Grade 1 CI Therapy +Sensory Components · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at follow-up at 3 months following the end of treatment.
Closest Location: University of Alabama at Birmingham · Birmingham, AL
Photo of university of alabama at birmingham 1Photo of university of alabama at birmingham 2Photo of university of alabama at birmingham 3
1991First Recorded Clinical Trial
26 TrialsResearching Stroke
1070 CompletedClinical Trials

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,402 Previous Clinical Trials
2,211,051 Total Patients Enrolled
33 Trials studying Stroke
47,559 Patients Enrolled for Stroke
David Morris, PhDStudy ChairUniversity of Alabama at Birmingham
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Stroke
12 Patients Enrolled for Stroke

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a stroke at least 6 months ago.
You have the ability to perform the minimum active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References