Stroke Clinical Trial
Official title:
Constraint-induced Movement Therapy to Improve Gait and Mobility of People With Chronic Stroke
NCT number | NCT03114046 |
Other study ID # | 000000 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | October 1, 2018 |
Verified date | January 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | October 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 5 times sit to stand | 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). | 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. | |
Secondary | 6 minutes walking test (6MWT) | The 6MWT assesses the energy expenditure during walking. It is a reliable and valid instrument in a diverse group of health conditions (11). | 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. | |
Secondary | Life-Space Assessment (LSA). | 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). | 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. |
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