NCT06747741

Brief Summary

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.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
Last Updated

December 24, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

December 18, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

ElderlyRestless Leg SyndromeSleep DisturbancePNF stretchingProprioceptive neuromuscular facilitation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

PNF Stretching technique Group

EXPERIMENTAL

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)

Conventional physical therapy Group

ACTIVE COMPARATOR

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

Interventions

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.

PNF Stretching technique Group

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)

Conventional physical therapy Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Restless Legs SyndromeParasomnias

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Central Study Contacts

Syeda Kainat Zehra, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 24, 2024

Study Start

June 20, 2024

Primary Completion

November 15, 2024

Study Completion

December 20, 2024

Last Updated

December 24, 2024

Record last verified: 2024-10

Locations