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

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ClinicalTrials.gov Identifier: NCT03114046
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Monteiro Dos Anjos, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Rehabilitation Recovery of Function Stroke Lower Extremity Paresis Behavioral: Lower extremity Constraint-induced movement therapy(LE-CIMT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Constraint-induced Movement Therapy to Improve Gait and Mobility of People With Chronic Stroke
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : October 1, 2018

Arm Intervention/treatment
Experimental: Baseline Phase
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.
Behavioral: Lower extremity Constraint-induced movement therapy(LE-CIMT)

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.





Primary Outcome Measures :
  1. Lower Extremity Motor Activity Log (LE-MAL) [ Time Frame: The LE-MAL will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the functional use of the paretic lower extremity will be assessed. The last 2 weeks (intervention) the trend of change will be assessed. ]
    is a semi-structured interview, created in the UAB CIMT laboratory, that consists of asks the participant the level of assistance, how well is her/his performance, and how much confident he/she is during the execution of 14 different daily tasks (e.g walking indoors, climb stairs) (6).

  2. Berg Balance Scale (BBS) [ Time Frame: The BBS will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of balance will be assessed. The last 2 weeks (intervention) the trend of change will be assessed. ]
    is a valid and reliable tool to assess balance control in 14 static and dynamic activities with people with different health conditions (7).

  3. 10 meters walking (10MWT) [ Time Frame: 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. ]
    is a gait speed measurement, which is an easy and reliable assessment of locomotion (8).


Secondary Outcome Measures :
  1. 5 times sit to stand [ Time Frame: The test will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the lower limb function will be assessed. The last 2 weeks (intervention) the trend of change will be assessed. ]
    Physical performance is commonly assessed by the 5-repetition-sit-to-stand test in a variety of populations, including stroke, elderly, and osteo-arthritis (9).

  2. 6 minutes walking test (6MWT) [ Time Frame: The 6MWT 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. ]
    The 6MWT assesses the energy expenditure during walking. It is a reliable and valid instrument in a diverse group of health conditions (11).

  3. Life-Space Assessment (LSA). [ Time Frame: 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. ]
    is an instrument developed by researchers at UAB that determines the area of action (e.g., distance and place) that a person uses to perform his/her daily activities (11).



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be 19 years old or older,
  • have more than 6 months after stroke;
  • present motor impairment on lower extremity due to stroke, but able to walk at least 25 feet using an assistive device or not, at least three times a day;
  • have no previous experience with any LE CIMT protocol.

Exclusion Criteria:

  • presence of uncontrolled clinical conditions;
  • presence of other neurologic diseases;
  • Mini-mental State Examination score <24
  • inability to answer yes and no questions properly;
  • score lower than 45 out of 56 on the Berg Balance Scale, and score higher than 5 on LEMAL, what indicates that they are already utilizing the paretic lower limb while performing daily activities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114046


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham

Publications:

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Responsible Party: Sarah Monteiro Dos Anjos, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03114046     History of Changes
Other Study ID Numbers: 000000
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms