Gait Training Combined With Behavioral Strategies for People With Stroke

NCT04546217 | Completed Results FDA Device

• 1 other identifier: IRB-300005407
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Gait, Hemiplegic; Behavior and Behavior Mechanisms

Keywords

Gait training; Robotic training; Transference; Behavioral strategies

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (3)

• 5-times-sit-to-stand - Functional Strength Assessment

  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.

• 6-minutes Walking Test - Energy Expenditure Assessment.

  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.

• Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment

  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.

Study Arms (2)

Treadmill training +Transfer package (TT+TP)

EXPERIMENTAL

The TT+TP group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. In combination with the gait training, participants in this group will also receive a group of behavioral strategies called the "Transfer Package" (TP). Each intervention session will last 1.5h, 1h for the gait training and 30 minutes dedicated for the transfer package. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change.

Combination Product: Treadmill training + transfer package (TT+TP)

Treadmill training (TT)

ACTIVE COMPARATOR

The TT group will receive 24 sessions (3x week for 8 weeks) of robotic treadmill gait training in a robotic device called KineAssist. Participants will be assessed pre-, post-intervention, 3 and 6 months after the end of the intervention. Also, participants will be interviewed to investigate their perceptions about each element of the intervention, benefits, side effects and suggestion for change.

Device: Treadmill training (TT)

Interventions

Treadmill training + transfer package (TT+TP) COMBINATION_PRODUCT

Participants will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. In combination with the gait training, participants will also receive a group of behavioral strategies (Transfer Package). Participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence.

Treadmill training +Transfer package (TT+TP)

Treadmill training (TT) DEVICE

Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.

Treadmill training (TT)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (15)

• 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.

  PMID: 28815562 BACKGROUND

• 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.

  PMID: 15554826 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

• Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.

  PMID: 17039224 BACKGROUND

• Mark VW, Taub E. Constraint-induced movement therapy for chronic stroke hemiparesis and other disabilities. Restor Neurol Neurosci. 2004;22(3-5):317-36.

  PMID: 15502259 BACKGROUND

• 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.

  PMID: 27056251 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

• 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.

  PMID: 31246610 BACKGROUND

• 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.

  PMID: 31899495 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

• 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

• 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

• 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.

  PMID: 21700763 BACKGROUND

• 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: 10.1002/14651858.CD001920.pub3.

  PMID: 24756870 RESULT

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Behavior

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

Limitations and Caveats

This study was affected by the COVID pandemic in multiple ways. The initial sample of 24 had to change to a minimum of 18 due to time constraints, leading us to a smaller sample that did not allow us to follow the planned statistical analysis. Due to institutional restrictions, the duration of the training changed to 6 weeks, instead of the planned 8 weeks. The recruitment was also impacted since all eligible participants were considered high risk of severe symptoms if exposed to the virus.

Results Point of Contact

• Title: Dr. Sarah dos Anjos
• Organization: University of Alabama at Birmingham

smanjos@uab.edu

2059347323

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not be involved nor present during the training sessions. Also the outcome assessments will be performed without the presence of the interventionist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 11, 2020
• Study Start: October 15, 2020
• Primary Completion: February 10, 2023
• Study Completion: February 21, 2023
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)