CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Treadmill training + transfer package (TT+TP) +1 morecombination
Likely dose
Not stated in record
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Search/NCT04546217
NCT04546217N/ACompleted

Gait Training Combined With Strategies to Induce Transference to Real Life for People With Stroke

University of Alabama at Birmingham·interventional·Posted Sep 11, 2020·Updated May 22, 2024

In Brief

A clinical study evaluating Treadmill training + transfer package (TT+TP) and Treadmill training (TT) for Stroke and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 11, 2020
Enrollment StartOct 15, 2020
Primary CompletionFeb 10, 2023
Study CompletionFeb 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.8 years ago

Interventions

Treadmill training + transfer package (TT+TP)combination

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 (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.