CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Lower extremity Constraint-induced movement therapy(LE-CIMT)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03114046
NCT03114046N/ACompleted

Constraint-induced Movement Therapy to Improve Gait and Mobility of People With Chronic Stroke

University of Alabama at Birmingham·interventional·Posted Apr 14, 2017·Updated Jan 23, 2023

In Brief

A clinical study evaluating Lower extremity Constraint-induced movement therapy(LE-CIMT) for Rehabilitation and 3 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 14, 2017
Enrollment StartJun 1, 2017
Primary CompletionSep 1, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.2 years ago

Interventions

Lower extremity Constraint-induced movement therapy(LE-CIMT)behavioral

Both phases (A and B) will last 10 weekdays, and during baseline and treatment phases, the data will be collected on 5 different odd days. Considering the long period of data collection. During the baseline phase, no assessment will be administered on even days. The treatment will be delivered daily, along 10 weekdays, 3.5 hours per day. The motor training will be delivered during 3 hours and 30 minutes will be allocated to the administration of the TP. Both caregivers and participants will be individually interviewed before and after treatment.