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Gait Training Combined With Behavioral Strategies for People With Stroke

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ClinicalTrials.gov Identifier: NCT04546217
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sarah Monteiro Dos Anjos, PhD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Stroke Gait, Hemiplegic Behavior and Behavior Mechanisms Combination Product: Treadmill training + transfer package (TT+TP) Device: Treadmill training (TT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Gait Training Combined With Strategies to Induce Transference to Real Life for People With Stroke
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : December 20, 2021

Arm Intervention/treatment
Experimental: Treadmill training +Transfer package (TT+TP)

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)
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.

Active Comparator: Treadmill training (TT)

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)
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.




Primary Outcome Measures :
  1. Lower Extremity Motor Activity Log - real world use of the effected Lower extremity [ Time Frame: Through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment. ]
    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 give when no assistance is needed, good quality of movement is reported and the person feels completely confident in performing the activity without falling.

  2. Berg Balance Scale - Balance assessment [ Time Frame: Through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up 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 score range from 0-56 and a score lower than 44 represents high risk of falling. The MDC of this scale for people with chronic stroke is 2.5 points.

  3. 10 meters walk test - Walking speed assessment [ Time Frame: Through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment. ]
    It is a gait speed measurement, which is an easy and reliable assessment of locomotion. A minimum change of 0.06m/s is considered Minimally Clinically Important Difference for the stroke population.


Secondary Outcome Measures :
  1. 5-times-sit-to-stand - functional strength assessment [ Time Frame: Through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment. ]
    Functional strength assessment tool. A performance time longer than 12 seconds is considered abnormal.

  2. 6-minutes walking test - energy expenditure assessment. [ Time Frame: Through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment. ]
    It is a tool to assess energy expenditure during walking. the Minimum Detectable Change (MDC) of the 6MWT is 34.4meters difference in people with chronic stroke.

  3. Fear of Falling Avoidance Questionnaire - avoidance behavior assessment [ Time Frame: Through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment. ]
    It is a questionnaire that identifies how the fear of falling has affected the performance of 14 activities. Higher scores indicate higher number of activities avoided due to to fear of falling.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04546217


Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Sarah M dos Anjos, MS, OT    205-420-9222    smanjos@uab.edu   
Principal Investigator: Sarah M dos Anjos, MS, OT         
Sponsors and Collaborators
University of Alabama at Birmingham
Publications of Results:
Other Publications:

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Responsible Party: Sarah Monteiro Dos Anjos, PhD, Teacher, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04546217    
Other Study ID Numbers: IRB-300005407
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
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: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sarah Monteiro Dos Anjos, PhD, University of Alabama at Birmingham:
Gait training
Robotic training
Transference
Behavioral strategies
Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations