- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459832
Optimal Duration of Stretching of the Hamstring Muscle Group in Elderly: A Randomized Controlled Trial
Optimal Time of Hamstring Stretch in Elderly
Study Overview
Detailed Description
Abstract:
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.
DESIGN: Randomized controlled trial Participants: In this trial, 100 participants will participate in the study diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups will stretched 5 times per week for 4 weeks for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures will be assessed immediately after the treatment session and 24 hours after the treatment session.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects had to demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects were also screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position
Exclusion Criteria:
- Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 15 second stretch
Stretching of the hamstring muscles was performed by the primary researcher for 15 seconds.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
Stretching of the hamstring muscles was performed by the primary researcher.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
|
Experimental: 30 second stretch
Stretching of the hamstring muscles was performed by the primary researcher for 30 seconds.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
Stretching of the hamstring muscles was performed by the primary researcher.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
|
Experimental: 60 second stretch
Stretching of the hamstring muscles was performed by the primary researcher for 60 seconds.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
Stretching of the hamstring muscles was performed by the primary researcher.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
|
Sham Comparator: control
The control group followed the same procedures except that no stretching force was applied at the end
|
Stretching of the hamstring muscles was performed by the primary researcher.
A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people.
All subjects were supine lying as flat as possible
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurophysiological findings.
Time Frame: Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session
|
Neurophysiological findings included peak to peak somatosensory evoked potentials (DSSEPs) for L3,L4,L5,S1 dermatomes.
|
Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM
Time Frame: Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session
|
Each subject was then measured for knee extension ROM on both lower extremities
|
Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A Randomized Controlled Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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