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临床试验/NCT04441801
NCT04441801已完成不适用

Optimal Duration of Stretching of the Hamstring Muscle Group : A Randomized Controlled Trial

University of Sharjah1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in dermatomal somatosensory evoked potentials immediately after treatment

研究概览

简要总结

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.

详细描述

A prospective, blinded, parallel-group, randomized clinical trial will be conducted in the research laboratory of our university. The patients will participate in the study after signing an informed consent form prior to data collection.

Inclusion Criteria Subjects who 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 will also be 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

Participants will be divided into four groups according to the stretching duration time (15, 30, and 60s, and the fourth group, which served as a control, did not stretch). The patients will randomly assigned to one of the four groups as follows. The randomization process will be based on permuted blocks of variable sizes. Each random permuted block, created randomly by a number generator, will be transferred to a sequence of consecutively numbered, opaque, sealed envelopes that will be kept in a locked drawer until needed. Once a subject was formally included in the trial, the next envelope in the sequence was opened by the researcher in the presence of the subject who would be assigned to a group according to the number found in the envelope.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
60 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: stretching exercise (Other)

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.

干预措施: stretching exercise (Other)

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.

干预措施: stretching exercise (Other)

control

Sham Comparator

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

干预措施: stretching exercise (Other)

结局指标

主要结局

Change in dermatomal somatosensory evoked potentials immediately after treatment

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

次要结局

  • change in range of motion(pre-treatment , immediately after treatment and at 24 hours after the treatment .)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Moustafa

Principal Investigator

University of Sharjah

研究点 (1)

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