- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07579520
Effects of Rhythmic Auditory Stimulation on Range of Motion in Post- Fracture Rehabilitation of Lower Limb
Effects of Rhythmic Auditory Stimulation on Pain and Range of Motion in Children With Post- Fracture Rehabilitation of Lower Limb
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, PhD*
- Phone Number: +923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- CLC
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Contact:
- MUBASHRA JABBAR
- Phone Number: 03291391075
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Contact:
- Javeria khan
- Phone Number: 03041862547
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 with pain perception and joint range of motion during recovery.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain in lowerlimb
Time Frame: 3 months
|
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.
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3 months
|
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Range of Motion
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jawad Ahmed, MS PPT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/G-III/RCR&AHS/B45-208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fracture of Lower Limb
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Hospital Clínico Universitario de ValladolidHospital Clinic of Barcelona; Hospital de Basurto; Complejo Hospitalario de Navarra and other collaboratorsRecruitingPeriprosthetic Fractures | Periprosthetic Fracture of the Upper or Lower Limb | Peri-implant Fracture of the Upper or Lower Limb | Peri-implant FractureSpain
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Cristália Produtos Químicos Farmacêuticos Ltda.Irmandade da Santa Casa de Misericordia de Sao Paulo; Serviço Social da Indústria...WithdrawnFracture of Lower LimbBrazil
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Benha UniversityActive, not recruitingLower Limb FractureEgypt
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Balgrist University HospitalRecruitingStress Fracture Metatarsal | Lower Limb Fracture | Stress Fracture Foot | Stress Fracture Ankle | Stress Fracture of TibiaSwitzerland
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Shanghai 6th People's HospitalNot yet recruitingSpinal Fractures | Fracture Lower Leg | Fracture Dislocation of Upper Limb Joint
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Armed Police Force Hospital, NepalNepal Orthopedic Hospital, Kathmandu, NepalNot yet recruiting
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Zagazig UniversityCompleted
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Kempegowda Institute of Medical Sciences, BangaloreCompletedLower Limb FractureIndia
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Karnataka Institute of Medical SciencesCompletedLower Limb FractureIndia
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University of WashingtonUnited States Department of DefenseRecruitingLower Limb; Fusion, Congenital | Lower Limb Fracture | Ankle Foot InjuryUnited States
Clinical Trials on Rhythmic Auditory Stimulation
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Boston University Charles River CampusNot yet recruiting
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Hospital Sociosanitari Mutuam GironaCompletedStroke | Gait, Hemiplegic | Gait Disorders, NeurologicSpain
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Chang Gung UniversityUnknown
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University of North Carolina, Chapel HillCompletedParkinson DiseaseUnited States
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Mahidol UniversityCompletedCerebral PalsyThailand
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Johns Hopkins UniversityRecruiting
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Pontifical Catholic University of ArgentinaUniversity of Buenos Aires; National Council of Scientific and Technical Research... and other collaboratorsWithdrawn
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IRCCS Eugenio MedeaEnrolling by invitationLanguage Development Disorders | Infant Development | Language Development | InterventionItaly
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YiCheng ZhuEnrolling by invitationParkinson Disease | Parkinsonian Syndrome | Hemiplegia Due to StrokeChina
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The Cleveland ClinicThe Kelvin and Eleanor Smith FoundationCompletedMultiple Sclerosis | Ambulation DifficultyUnited States