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Behavioral Intervention

Baseline Phase for Stroke

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the 10mwt will be administered 10 times along 4 weeks. during the first 2 weeks (baseline phase) the stability of the gait function will be assessed. the last 2 weeks (intervention) the trend of change will be assessed.
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this single-subject, concurrent mixed methods study is to investigate the relationship between the effect of the CIMT protocol on gait and mobility and participants' and caregivers' expectations and perceptions regarding the treatment. The goal of the quantitative strand is to assess changes in quality of movement and functional use of the paretic lower limb after the treatment and investigate the participants' expectations in regards the intervention using the Participant Opinion Survey (POS). The qualitative strand (participant interviews) will determine perspectives of caregiver and participant perspectives regarding protocol acceptability. Both quantitative and qualitative data will be collected and analyzed concurrently, through triangulation and complementarity rationales; both data will be equally prioritized.

Eligible Conditions
  • Stroke
  • Rehabilitation
  • Weakness in the Lower Extremities

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the test will be administered 10 times along 4 weeks. during the first 2 weeks (baseline phase) the stability of the mobility status will be assessed. the last 2 weeks (intervention) the trend of change will be assessed.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the test will be administered 10 times along 4 weeks. during the first 2 weeks (baseline phase) the stability of the mobility status will be assessed. the last 2 weeks (intervention) the trend of change will be assessed. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
10 meters walking (10MWT)
Berg Balance Scale (BBS)
Lower Extremity Motor Activity Log (LE-MAL)
Secondary study objectives
5 times sit to stand
6 minutes walking test (6MWT)
Life-Space Assessment (LSA).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Baseline PhaseExperimental Treatment1 Intervention
This project will conduct a single-subject pre-experimental AB mixed methods design, considering A phase as the baseline strand. During this phase multiple assessments will be administered. This phase will last 2 consecutive weeks, with 5 visits total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lower extremity Constraint-induced movement therapy(LE-CIMT)
2017
N/A
~10

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,636 Previous Clinical Trials
2,305,146 Total Patients Enrolled
36 Trials studying Stroke
86,739 Patients Enrolled for Stroke
~1 spots leftby Oct 2025
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