Effects of PNF Stretching vs Conventional Physical Therapy on the Symptoms of Restless Leg Syndrome in Elderly Population.

December 18, 2024 updated by: Foundation University Islamabad

Restless leg Syndrome (RLS) is a common condition in the elderly population,characterized byan uncontrollable urge to move the leg,often occuring in the evening or at night,which can significantly disturb sleep and daily activities(ADL).

Although various type of stretchings found to be effective on the symptoms of RLS,no study has specifically compared the effects of Proprioceptive Neuromuscular Facilitation stretching technique versus conventional physical therapy on the symptoms of RLS and related sleep disturbances.This study aims to fill this gap by evaluating the effectiveness of PNF stretching compared to conventional physical therapy,on the symptoms of RLS in elderly population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES:

Objectives of this study are:

  1. To determine the effect of PNF stretching VS conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
  2. To determine the effect of PNF stretching VS conventional physical therapy on sleep disturbance related to restless leg syndrome in elder population.

HYPOTHESIS:

Alternate Hypothesis:

  1. There is statistically significant difference between the effect of PNF stretching VS Conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
  2. There is statistically significant difference between the effect of PNF stretching VS conventional physical therapy on the sleep disturbance related to restless leg syndrome in elder population.

Null Hypothesis:

  1. There is no statistically significant difference between the effect of PNF stretching VS conventional physical therapy on the symptoms of Restless leg syndrome in elder population.
  2. There is no statistically significant difference between the effect of PNF stretching VS conventional physical therapy on sleep disturbance related to restless leg syndrome in elder population.

Study Design: Randomized Controlled Trial

Clinical setting: Fauji foundation Hospital(Rehab Depart) Islamabad Healing Center. Study Duration: 1year

SELECTION CRITERIA:

Inclusion Criteria:

  1. Age 60 and above.
  2. Both male and female.
  3. Must fulfil the diagnostic criteria of primary restless leg syndrome.

Exclusion Criteria:

1.A history or underlying disease that would contribute to the syptoms of RLS.

Sampling Technique:Non probability purposive samping.

Data will be collected on demographics and general information. Data will be coollected using International Restless leg syndrome rating scale,Post-sleep questionnaire.

Experimental Group:This group will receive PNF stretching technique of Hold-relax with agonist contraction,outcome will measure before and after the treatment of 4 weeks.

Control Group:This group will receive conventional physical therapy,Outcome will measure before and after 4 weeks of treatment.

Data will be analyze through SPSS21 and data will be analyzed based on study design choosen that is Randomize control study with in the community.

The printed questionnaire will be provided to the patients after obtaining written consent and providing adequate information regarding the study,after which the data will be presented in the form of graphs or tables.

Significance of the study:

Although PNF stretching proves to be more effective in reducing pain increasing ROM and flexibility,but there is limited documentation about its effect on RLS.

This study aims to uncover and augument the treatment strategies that can wield even more favourable results in elder population dealing with Restless leg syndrome and also sleep disturbance related to it.

So it will aid therapist in choosing right technique saving their time and patient's investment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Recruiting
        • Foundation University College of Physical Thrapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 60 and above.
  • Male & Females both.
  • must fulfill the diagnostic criteria of primary RLS.

Exclusion Criteria:

  • A history or underlying disease that would contribute to the symptoms of RLS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNF Stretching technique Group
The participants will receive PNF stretching technique of contract-Relax with agonist contraction for 3 days per week on alternate days for the symptoms of RLS in elderly population.
Procedure: PNF stretching(Contract relax with agonist contraction)
1.Passively dorsiflex the patient's foot then ask to perform active planterflexion against resistance and hold for 7-10 sec then ask patient to perform dorsiflexion to the maximum available range.
Active Comparator: Conventional physical therapy Group
The participants will receive Conventional physical therapy including calf stretchinf and strenthening exercises, 3 days per week on alternative days for the symptoms of RLS in elder population.
Procedure: Conventional physical therapy

Static Stretching:(Seated Calf Stretch With a Resistance Band)

  1. Sit on the floor with your legs extended.
  2. Loop a resistance band around one foot, holding both sides of it with your hands.
  3. Gently pull your toes toward your shin until you feel the stretch in your calf.Repeat on the other side.

Isometric Calf Raise:

  1. Stand with feet shoulder-width apart and arms at sides.
  2. Engage your abs for stability and roll up onto the balls of your feet, lifting both heels off the floor.
  3. Hold for 5 seconds, then return to the starting position. Frequency : 5 reps with 5-7Sec hold,3 days per week for 4 weeks (alternatively)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of restless leg syndrome symptoms
Time Frame: 4 weeks
International Restless leg syndrome rating scale is 10 item Questionnaire,each question has 0(None) to 4(very severe) grading.Total score is 40,Mild(1-10),Moderate(11-20),Severe(21-30),Very severe(31-40).Participant will be assessed through this scoring system for the severity of RLS symptoms.
4 weeks
Sleep disturbance related to RLS
Time Frame: 4 weeks
5 Item questionnaire related to quality of sleep.Higher score indicate higher sleep disturbance.quality of sleep of participant will be assess through this questionnaire.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2024/44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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