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Recruiting NCT07579520

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

No phase Interventional Fracture of Lower Limb

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rhythmic Auditory Stimulation.
Who it may be relevant to
Registry conditions: Fracture of Lower Limb. Basic parameters: 5 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Rhythmic Auditory Stimulation on Pain and Range of Motion in Children With Post- Fracture Rehabilitation of Lower Limb

Overview

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.

Detailed description

Despite notable advancements in pediatric orthopedic rehabilitation, effective pain management and the restoration of functional range of motion continue to present significant challenges for children recovering from lower limb fractures. Traditional physiotherapy interventions largely emphasize manual therapy and structured exercise programs, often supplemented with pharmacological pain management. However, reliance on medications may lead to potential side effects and can negatively impact treatment adherence, particularly in pediatric populations. As a result, there is increasing interest in non-pharmacological approaches that can enhance rehabilitation outcomes while minimizing risks.

One such approach, Rhythmic Auditory Stimulation (RAS), has demonstrated considerable effectiveness in neurorehabilitation settings, including in conditions such as stroke, Parkinson's disease, and cerebral palsy. In these populations, RAS has been shown to improve motor coordination, regulate gait patterns, and positively influence pain perception through the use of rhythmic cues. Despite these promising outcomes, there remains a clear gap in the literature regarding the application of RAS within pediatric orthopedic rehabilitation, especially for children recovering from fractures.

Exploring the role of RAS in this specific context could provide valuable insights into its potential as an adjunct to conventional therapy. Integrating rhythmic auditory cues into rehabilitation programs may not only support improved physical outcomes, such as enhanced joint mobility and reduced pain, but also contribute to better emotional engagement and overall patient experience. Addressing this gap is essential for advancing evidence-based practice, expanding the use of innovative therapeutic techniques, and ultimately improving the quality of care and satisfaction for pediatric patients and their families.

Interventions

  • Other Rhythmic Auditory Stimulation
    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.

Primary outcome measures

  • Pain in lowerlimb [Time frame: 3 months]
  • Range of Motion [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • CLC — Lahore

Publications

  • 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

Identifiers

NCT: NCT07579520 · Riphah/G-III/RCR&AHS/B45-208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗