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Treadmill training +Transfer package (TT+TP) for Stroke
N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment.
Awards & highlights
Study Summary
This trial will explore the effect of combining a group of behavioral strategies called Transfer Package with robotic gait training to improve walking and balance skills after stroke.
Eligible Conditions
- Stroke
- Hemiplegic Gait
- Behavioral Mechanisms
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 months to investigate long-term changes from baseline to 6 months follow up assessment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10 meters walk test - Walking speed assessment
Berg Balance Scale - Balance assessment
Lower Extremity Motor Activity Log - real world use of the effected Lower extremity
Secondary outcome measures
5-times-sit-to-stand - functional strength assessment
6-minutes walking test - energy expenditure assessment.
Fear of Falling Avoidance Questionnaire - avoidance behavior assessment
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treadmill training +Transfer package (TT+TP)Experimental Treatment1 Intervention
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.
Group II: Treadmill training (TT)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treadmill training + transfer package (TT+TP)
2020
N/A
~20
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,580 Previous Clinical Trials
2,275,976 Total Patients Enrolled
36 Trials studying Stroke
87,365 Patients Enrolled for Stroke
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity to partake in the trial at this time?
"According to the clinicaltrials.gov website, this trial is no longer actively recruiting participants; it has been posted since October 15th 2020 and last updated on September 13th 2022. However, there are currently 1,088 other trials searching for candidates at present."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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