Gait Training Combined With Behavioral Strategies for People With Stroke

NCT04546217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-05-22

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2023-02-10
Completion
2023-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546217 on ClinicalTrials.gov