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

NCT ID: NCT06747741

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Restless Leg Syndrome (RLS) Proprioceptive Neuromuscular Facilitation Sleep Disturbance

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Elderly Restless Leg Syndrome Sleep Disturbance PNF stretching Proprioceptive neuromuscular facilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PNF stretching(Contract relax with agonist contraction)

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foundation University College of Physical Thrapy

Islamabad, , Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Syeda Kainat Zehra, DPT

Role: CONTACT

Phone: +923045141136

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sana Khalid, MS-NMPT

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FUI/CTR/2024/44

Identifier Type: -

Identifier Source: org_study_id