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

NCT03114046 | Completed

• 1 other identifier: 000000
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation; Recovery of Function; Stroke; Lower Extremity Paresis

Outcome Measures

Primary Outcomes (3)

• Lower Extremity Motor Activity Log (LE-MAL)

  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).

  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.

• Berg Balance Scale (BBS)

  is a valid and reliable tool to assess balance control in 14 static and dynamic activities with people with different health conditions (7).

  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.

• 10 meters walking (10MWT)

  is a gait speed measurement, which is an easy and reliable assessment of locomotion (8).

  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.

Secondary Outcomes (3)

• 5 times sit to stand

  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.

• 6 minutes walking test (6MWT)

  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.

• Life-Space Assessment (LSA).

  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.

Study Arms (1)

Baseline Phase

EXPERIMENTAL

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)

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.

Baseline Phase

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (10)

• Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12. doi: 10.1016/s0003-9993(95)80568-0.

  PMID: 7741609 BACKGROUND

• Taub E, Uswatte G, Mark VW, Morris DM, Barman J, Bowman MH, Bryson C, Delgado A, Bishop-McKay S. Method for enhancing real-world use of a more affected arm in chronic stroke: transfer package of constraint-induced movement therapy. Stroke. 2013 May;44(5):1383-8. doi: 10.1161/STROKEAHA.111.000559. Epub 2013 Mar 21.

  PMID: 23520237 BACKGROUND

• Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005.

  PMID: 19801058 BACKGROUND

• Byiers BJ, Reichle J, Symons FJ. Single-subject experimental design for evidence-based practice. Am J Speech Lang Pathol. 2012 Nov;21(4):397-414. doi: 10.1044/1058-0360(2012/11-0036). Epub 2012 Oct 15.

  PMID: 23071200 BACKGROUND

• Mark VW, Taub E, Uswatte G, Bashir K, Cutter GR, Bryson CC, Bishop-McKay S, Bowman MH. Constraint-induced movement therapy for the lower extremities in multiple sclerosis: case series with 4-year follow-up. Arch Phys Med Rehabil. 2013 Apr;94(4):753-60. doi: 10.1016/j.apmr.2012.09.032. Epub 2012 Oct 27.

  PMID: 23111280 BACKGROUND

• Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995 Mar;27(1):27-36.

  PMID: 7792547 BACKGROUND

• Green J, Forster A, Young J. Reliability of gait speed measured by a timed walking test in patients one year after stroke. Clin Rehabil. 2002 May;16(3):306-14. doi: 10.1191/0269215502cr495oa.

  PMID: 12017517 BACKGROUND

• Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.

  PMID: 20298832 BACKGROUND

• Eng JJ, Dawson AS, Chu KS. Submaximal exercise in persons with stroke: test-retest reliability and concurrent validity with maximal oxygen consumption. Arch Phys Med Rehabil. 2004 Jan;85(1):113-8. doi: 10.1016/s0003-9993(03)00436-2.

  PMID: 14970978 BACKGROUND

• Peel C, Sawyer Baker P, Roth DL, Brown CJ, Brodner EV, Allman RM. Assessing mobility in older adults: the UAB Study of Aging Life-Space Assessment. Phys Ther. 2005 Oct;85(10):1008-119.

  PMID: 16180950 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 14, 2017
• Study Start: June 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)