Effects of Rhythmic Auditory Stimulation on Range of Motion in Post- Fracture Rehabilitation of Lower Limb

NCT07579520 | Recruiting

• 1 other identifier: Riphah/G-III/RCR&AHS/B45-208
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of rhythmic auditory stimulation on pain levels and range of motion in children undergoing post-fracture rehabilitation of the lower limb. It seeks to determine whether incorporating rhythmic auditory cues can help reduce pain and improve joint mobility during the recovery process.

Conditions

Fracture of Lower Limb

Keywords

Pain; Range of Motion; Post- Fracture Rehabilitation; Rehabilitation of Lower Limb; Auditory Stimulation

Outcome Measures

Primary Outcomes (2)

• Pain in lowerlimb

  changes from baseline in Pain will be assessed to determine the effectiveness of rhythmic auditory stimulation (RAS) during post-fracture rehabilitation in children with lower limb injuries. Measurements will be taken before and after the intervention using an appropriate pediatric pain scale to evaluate any reduction in pain levels associated with the incorporation of rhythmic auditory cues alongside standard physiotherapy.

  3 months

• Range of Motion

  changes from baseline in Range of motion (ROM) refers to the degree of movement achieved at the affected lower limb joint during post-fracture rehabilitation. It will be measured before and after the intervention to assess improvements in joint mobility following the application of Rhythmic Auditory Stimulation in combination with standard physiotherapy.

  3 months

Study Arms (1)

Rhythmic Auditory Stimulation

EXPERIMENTAL

The intervention involves applying Rhythmic Auditory Stimulation (RAS) through structured rhythmic cues or music during rehabilitation sessions alongside standard physiotherapy for children with lower limb fractures. These rhythmic cues are synchronized with movement exercises to help with pain perception and joint range of motion during recovery.

Other: Rhythmic Auditory Stimulation

Interventions

Rhythmic Auditory Stimulation OTHER

The intervention involves applying Rhythmic Auditory Stimulation (RAS) through structured rhythmic cues or music during rehabilitation sessions alongside standard physiotherapy for children with lower limb fractures. These rhythmic cues are synchronized with movement exercises to help reduce pain perception and enhance joint range of motion during recovery.

Rhythmic Auditory Stimulation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age range typically 5 to18 years
• Closed lower limb fracture (tibia, fibula, femur, ankle) treated non-surgically with immobilization (e.g., cast, splint, brace)
• Patients in rehabilitation stage (not immediate post-op trauma care)
• Sub-acute or post-casting phase where active ROM and gait training are clinically indicated
• Post-Fracture Stage: Within 4-6 weeks post-fracture
• Ability to Participate
• Able to follow instructions and participate in RAS sessions
• Medically stable and cleared for physical therapy.

You may not qualify if:

• Acute emergency management studies
• Presence of multiple fractures or other significant injuries.
• Known hearing impairments that may affect response to auditory stimulation.
• Presence of cognitive or neurological impairments that may affect participation.
• Pre-existing chronic pain conditions that may confound pain assessments.
• Recent surgeries or medical conditions that may contraindicate physical therapy or RAS.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

CLC

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Liu H, Wang H, Shao B, Lu H, Zhang S, Ou L, Chen Y, Xiang L. Epidemiological evaluation of traumatic lower limb fractures in children: Variation with age, gender, time, and etiology. Medicine (Baltimore). 2019 Sep;98(38):e17123. doi: 10.1097/MD.0000000000017123.

  PMID: 31567950 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jawad Ahmed, MS PPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, PhD*

CONTACT

+923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In a quasi-experimental pre-test/post-test single-group design, full blinding is generally not feasible. Since all participants receive the same intervention and there is no comparison or control group, both the participants and the therapist are usually aware of the treatment being given, making participant and therapist blinding impractical. However, partial blinding can still be applied. For example, the outcome assessor (the person measuring pain or range of motion) can be blinded to the study objectives or the timing of assessment (pre vs. post) to reduce measurement bias. Similarly, data analysts can be blinded to the intervention phase when analyzing results. While full blinding is limited in this design, implementing assessor or analyst blinding can still improve the validity and reliability of the study findings.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Since there is no separate control group, participants serve as their own controls, and any differences observed between pre- and post-intervention outcomes are attributed to the intervention, although external factors cannot be entirely ruled out. This model is commonly used in clinical and rehabilitation settings where control groups may not be feasible, and it allows researchers to assess the preliminary effectiveness, feasibility, and clinical impact of an intervention.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: April 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)