NCT04441801

Brief Summary

OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM. DESIGN: Randomized controlled trial Participants: In this trial, 168 participants 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 was stretched 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 were assessed immediately after the treatment session and 24 hours after the treatment session.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

June 12, 2020

Last Update Submit

October 29, 2020

Conditions

Keywords

StretchingRandomized controlled trialHamstring

Outcome Measures

Primary Outcomes (1)

  • Change in dermatomal somatosensory evoked potentials immediately after treatment

    In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at \< 5 k Cutaneous areas of L3,L4,L5, S1 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.

    pre-treatment , immediately after treatment and at 24 hours after the treatment .

Secondary Outcomes (1)

  • change in range of motion

    pre-treatment , immediately after treatment and at 24 hours after the treatment .

Study Arms (4)

15 seconds

EXPERIMENTAL

Stretching of the hamstring muscles will be performed by the primary researcher. A straight-leg-raising technique will be 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, each subject's knee will be maintained in extension with the ankle at 90 degrees without medial (internal) or lateral (external) rotation of the lower extremity, and the extremity was raised until the subject reported discomfort. The subject was asked to relax the lower extremity in an effort to prevent contracting muscles from affecting the stretch and to allow for a slow stretch. stretching will continue for 15 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times.

Other: stretching exercise

30 seconds

EXPERIMENTAL

the same stretching technique will continue for 30 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times.

Other: stretching exercise

60 seconds

EXPERIMENTAL

the same stretching technique will continue for 60 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times.

Other: stretching exercise

control

SHAM COMPARATOR

The control group followed the same procedures except that no stretching force was applied at the end.

Other: stretching exercise

Interventions

Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position

15 seconds30 seconds60 secondscontrol

Eligibility Criteria

Age60 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with "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.

You may not qualify if:

  • Using of medical aids.
  • suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibrahim Moustafa

Sharjah city, United Arab Emirate, 27272, United Arab Emirates

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ibrahim Moustafa, professor

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor, who took the measurements for both the intervention and control groups, was blinded to the subject's group, while the treating therapist was not blinded to the treatment intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 3 intervention groups .The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 22, 2020

Study Start

June 5, 2020

Primary Completion

September 1, 2020

Study Completion

September 20, 2020

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

no plan to make individual participant data (IPD) available to other researchers.

Locations