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

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: Recruiting
• Conditions: Sleep Disturbance; Elderly; Restless Leg Syndrome (RLS); Proprioceptive Neuromuscular Facilitation
• Intervention / Treatment: Procedure: PNF stretching(Contract relax with agonist contraction); Procedure: Conventional physical therapy

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: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syeda Kainat Zehra, DPT; Phone Number: +923045141136; Email: syedazara434@gmail.com

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Recruiting
    • Foundation University College of Physical Thrapy
    • Contact: Sana Khalid, MS-NMPT; Phone Number: +923444218174; Email: sana.khalid@fui.edu.pk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Sit on the floor with your legs extended.; Loop a resistance band around one foot, holding both sides of it with your hands.; Gently pull your toes toward your shin until you feel the stretch in your calf.Repeat on the other side. Isometric Calf Raise: Stand with feet shoulder-width apart and arms at sides.; Engage your abs for stability and roll up onto the balls of your feet, lifting both heels off the floor.; 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

Outcome Measure	Measure Description	Time Frame
Severity of restless leg syndrome symptoms	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	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

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Sleep Disturbance; Proprioceptive neuromuscular facilitation; Restless Leg Syndrome; PNF stretching
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Behavioral Symptoms; Disease; Neurobehavioral Manifestations; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyskinesias; Psychomotor Disorders; Syndrome; Dyssomnias; Parasomnias; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID 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