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

NCT07579520 | Completed

• 1 other identifier: RCR/RCR&AHS/25/0748
• 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)

• Change in Pain Intensity in Lower Limb

  Change in pain intensity will be assessed to determine the effectiveness of Rhythmic Auditory Stimulation (RAS) during post-fracture rehabilitation in children with lower limb injuries. Pain will be measured using the Wong-Baker Faces Pain Rating Scale. Assessments will be conducted before and after each rehabilitation session. Time Frame: Baseline to 3 months Measurement: Wong-Baker Faces Pain Rating Scale. Score range 0 to 10. A score of 0 indicates no pain and a score of 10 indicates worst possible pain. Higher scores indicate a worse outcome.

  3 months

• Change in Lower Limb Joint Range of Motion

  Change in joint range of motion will be assessed to evaluate the effect of Rhythmic Auditory Stimulation (RAS) on mobility during post-fracture rehabilitation in children with lower limb injuries. Range of motion will be measured in degrees using a standard universal goniometer by a trained physiotherapist. Time Frame: Baseline to 3 months Measurement: Degrees of joint motion. Higher degree values indicate a better outcome.

  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 (RAS)

Interventions

Rhythmic Auditory Stimulation (RAS) OTHER

Participants will receive Rhythmic Auditory Stimulation (RAS) during rehabilitation sessions. Structured rhythmic cues or music will be delivered and synchronized with therapeutic movement exercises. The goal is to reduce pain perception and enhance joint range of motion during recovery in children with lower limb fractures. All participants will receive standard physiotherapy according to hospital protocol. This includes range of motion exercises, strengthening exercises, gait training, and pain management as prescribed by the treating physiotherapist.

Also known as: Standard Physiotherapy

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

Location

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

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: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)