Fracture of Lower LimbNCT07579520
Effects of Rhythmic Auditory Stimulation on Range of Motion in Post- Fracture Rehabilitation of Lower Limb
A study testing Rhythmic Auditory Stimulation (RAS) in people with Fracture of Lower Limb, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Fracture of Lower Limb
- What is being tested?
- Rhythmic Auditory Stimulation (RAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rhythmic Auditory Stimulation on Pain and Range of Motion in Children With Post- Fracture Rehabilitation of Lower Limb
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.
Read the 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.
- Conditions
- Fracture of Lower Limb
- Being tested
- Rhythmic Auditory Stimulation (RAS)
- Keywords
- Pain, Range of Motion, Post- Fracture Rehabilitation, Rehabilitation of Lower Limb, Auditory Stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Auditory Stimulation (RAS)Other
Also called Standard Physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rhythmic Auditory Stimulation (RAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Apr 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of Lower LimbStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jawad Ahmed, MS PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579520
- Sponsor's protocol ID
- RCR/RCR&AHS/25/0748
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31567950
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Auditory Stimulation on Pain and Range of Motion in Children With Post- Fracture Rehabilitation of Lower Limb
- ClinicalTrials.gov ID
- NCT07579520
- Acronym / sponsor ID
- RCR/RCR&AHS/25/0748
- Conditions
- Fracture of Lower Limb
- Keywords
- Pain, Range of Motion, Post- Fracture Rehabilitation, Rehabilitation of Lower Limb, Auditory Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Auditory Stimulation | Experimental | Other: Rhythmic Auditory Stimulation (RAS)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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic Auditory Stimulation (RAS)Also: Standard PhysiotherapyParticipants 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. | Other | Rhythmic Auditory Stimulation |
Primary outcome
Change in Pain Intensity in Lower Limb
Time frame: 3 months
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.
Change in Lower Limb Joint Range of Motion
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 31567950Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jawad Ahmed, MS PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Auditory Stimulation (RAS) in people with Fracture of Lower Limb, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity in Lower Limb (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07579520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.