Mode
Text Size
Log in / Sign up
N/A N=19 Randomized Single-blind Treatment

Gait Training Combined With Behavioral Strategies for People With Stroke

Stroke · Gait, Hemiplegic · Behavior and Behavior Mechanisms

Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities. — 6.3; 6.4; 7.3; 7.2 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Treadmill training + transfer package (TT+TP) (Combination_product); Treadmill training (TT) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Alabama at Birmingham
Primary completion
Feb 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities.
6.3; 6.4; 7.3; 7.2; 7.4; 7.5
PRIMARY
Berg Balance Scale - Balance Assessment
44.8; 47.5; 46.4; 50.2; 46.3; 50.0
PRIMARY
10 Meters Walk Test - Walking Speed Assessment
0.42; 0.46; 0.46; 0.50; 0.53; 0.59
SECONDARY
5-times-sit-to-stand - Functional Strength Assessment
18.3; 20.3; 17.2; 18.0; 17.0; 17.0
SECONDARY
6-minutes Walking Test - Energy Expenditure Assessment.
147.1; 168.2; 170.5; 184.5; 191.2; 212.4
SECONDARY
Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment
16.3; 14.0; 16.0; 12.8; 16.1; 16.3

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04546217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search