- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Imran Amjad, PhD
- Telefonnummer: 03324390125
- E-post: imran.amjad@riphah.edu.pk
Studer Kontakt Backup
- Navn: Muhammad Asif Javed, PhD*
- Telefonnummer: +923224209422
- E-post: a.javed@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
- CLC
-
Ta kontakt med:
- MUBASHRA JABBAR
- Telefonnummer: 03291391075
-
Ta kontakt med:
- Javeria khan
- Telefonnummer: 03041862547
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain in lowerlimb
Tidsramme: 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.
|
3 months
|
|
Range of Motion
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jawad Ahmed, MS PPT, Riphah International University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Riphah/G-III/RCR&AHS/B45-208
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .