Stroke Clinical Trial
Official title:
Gait Training Combined With Strategies to Induce Transference to Real Life for People With Stroke
Verified date | April 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A variety of rehabilitation techniques focused on improving disability after stroke have shown significant changes on walking speed, and endurance. Also, the administration of combined techniques showed better results. Previous studies have suggested that embedding behavioral strategies in neurorehabilitation protocols can enhance patient's adherence and participation outside the clinical setting. The addition of a group of behavioral strategies called Transfer Package (TP) has been widely used in motor training protocol (e.g. Constraint-Induced Movement Therapy). The TP has shown to enhance the effects of treatment 2.4 times when compared to motor training alone. However, the effect of TP when combined with robotic gait training remains unexplored. In this study our goal is to combine the TP with robotic gait training. The hypothesis is that using the TP in combination with robotic gait training will enhance the outcome of robotic gait training alone and will induce long term transference and retention of the motor skills observed after treatment. More importantly, this experimental intervention is more meaningful to the patient and can be more easily implemented on the clinical setting. The aims of this study are (1) to assess transfer and long-term retention of walking and balance skills after robotic treadmill gait training combined with the TP, (2) to understand participants' acceptability and perceptions of the TP as a tool to enhance transfer of skills to real-world situations, and (3) to examine the feasibility of these combined intervention to improve walking and balance after stroke.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 21, 2023 |
Est. primary completion date | February 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older; - at least 6 months post stroke; - present lower extremity motor impairment secondary to stroke; - able to walk at least 10 feet with or without personal assistance; - discharged from rehabilitation. Exclusion Criteria: - presence of uncontrolled clinical conditions; - weight > 400lb because this is limit supported by the KineAssist - other neurologic conditions; - Mini-Mental State Examination score (MMSE) <24; - inability to provide the informed consent; - insufficient language skills to answer the screening, assessments and interview questions. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
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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
Dos Anjos S, Morris D, Taub E. Constraint-Induced Movement Therapy for Lower Extremity Function: Describing the LE-CIMT Protocol. Phys Ther. 2020 Apr 17;100(4):698-707. doi: 10.1093/ptj/pzz191. — View Citation
Dos Anjos SM, Morris DM, Taub E. Constraint-Induced Movement Therapy for Improving Motor Function of the Paretic Lower Extremity After Stroke. Am J Phys Med Rehabil. 2020 Jun;99(6):e75-e78. doi: 10.1097/PHM.0000000000001249. — 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
Landers MR, Durand C, Powell DS, Dibble LE, Young DL. Development of a scale to assess avoidance behavior due to a fear of falling: the Fear of Falling Avoidance Behavior Questionnaire. Phys Ther. 2011 Aug;91(8):1253-65. doi: 10.2522/ptj.20100304. Epub 2011 Jun 23. — 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
Mark VW, Taub E. Constraint-induced movement therapy for chronic stroke hemiparesis and other disabilities. Restor Neurol Neurosci. 2004;22(3-5):317-36. — View Citation
Mehrholz J, Thomas S, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2017 Aug 17;8(8):CD002840. doi: 10.1002/14651858.CD002840.pub4. — 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
Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68. — View Citation
Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/146 — View Citation
Stretton CM, Mudge S, Kayes NM, McPherson KM. Interventions to improve real-world walking after stroke: a systematic review and meta-analysis. Clin Rehabil. 2017 Mar;31(3):310-318. doi: 10.1177/0269215516640863. Epub 2016 Jul 10. — 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
Taub E. Harnessing brain plasticity through behavioral techniques to produce new treatments in neurorehabilitation. Am Psychol. 2004 Nov;59(8):692-704. doi: 10.1037/0003-066X.59.8.692. No abstract available. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities. | It is a semi-structured interview that consists of questions asking the participant the level of assistance, how well her/his performance is, and level of confidence while executing 14 different daily tasks (e.g. walking indoors, climbing stairs) in real world environment. The LE-MAL investigates the transference of the skills addressed during the treatment to different contexts. The LE-MAL is a reliable tool in both test-retest results (r=0.93) and internal consistency (Cronbach's alpha = 0.96). The score range from 0-10, where 0 is a higher level of assistance, worse quality and movement and less confidence, and 10 is given when no assistance is needed, good quality of movement is reported and the person feels completely confident in performing the activity without falling. | Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention. | |
Primary | Berg Balance Scale - Balance Assessment | It is a valid and reliable tool to assess balance control in both static and dynamic activities with people with different health conditions. The Berg includes 14 balance tasks, each one scored from 0 (inability to perform or need for maximum assistance) to 4 (able to perform the task without difficulty or independently). The total score range from 0-56 and a score lower than 44 represents high risk of falling. | Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention. | |
Primary | 10 Meters Walk Test - Walking Speed Assessment | It is a gait speed measurement, which is an easy and reliable assessment of locomotion. In this assessment, the individual is asked to walk 10 meter, with or without an assistive decide, and the speed is calculated according to the time the individual takes from the beginning to the end of the 10 meter trail. During the self-selected speed, the individual is asked to walk at his/her/their normal speed, as if the person is walking at home. On the fast speed, the individual is asked to speed up and walk fast as he/she/they can, but not running. | Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention. | |
Secondary | 5-times-sit-to-stand - Functional Strength Assessment | Functional strength assessment tool. In this assessment, the individual is asked to stand up and sit on a chair 5 times and the time spend to perform the task is recorded. A performance time longer than 12 seconds is considered abnormal. | Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention. | |
Secondary | 6-minutes Walking Test - Energy Expenditure Assessment. | It is a tool to assess energy expenditure and endurance during walking. The total distance in meters that the individual walked in a 6 minutes period is recorded. | Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention. | |
Secondary | Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment | In this assessment, the individuals are asked about activities that they avoid due to their fear of falling. It is a questionnaire that identifies how the fear of falling has affected the performance of 14 activities scored from 0 to 4 where 0 means "I completely disagree that I avoid this activity because I am afraid of falling", and 4 means "I completely agree that I avoid this activity because I am afraid of falling". The total score ranges from 0 to 56 where higher scores indicate higher number of activities avoided due to their fear of falling. | Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention. |
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