- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07655973
Foot Intensive Rehabilitation With Perturbation Based Training in Ankle Sprain Patients
Foot Intensive Rehabilitation With & Without Perturbation Based Training in Patients With Ankle Sprain
To determine the foot-intensive rehabilitation with and without perturbation-based training on pain reduction, range of motion improvement, balance enhancement, and functional instability in patients recovering from ankle sprains NULL HYPOTHESIS There will be no significant difference in the effectiveness of foot-intensive rehabilitation with perturbation-based training compared to foot-intensive rehabilitation alone in reducing pain, improving range of motion, enhancing balance, or reducing functional instability among patients recovering from ankle sprains.
ALTERNATE HYPOTHESIS There will be a significant difference in pain reduction, range of motion improvement, balance enhancement, and reduction in functional instability between patients undergoing foot- intensive rehabilitation with perturbation-based training compared to those undergoing foot-intensive rehabilitation.
Study Design:
It will be a Randomized Clinical Trial
Study Population:
Ankle Sprain Both groups will undergo the assigned interventions for the duration of 6 weeks under the supervision of trained physical therapists or healthcare professionals. The interventions will aim to address pain reduction, range of motion improvement, balance enhancement, and reduction in functional instability among participants recovering from ankle sprains.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Group A: Foot-Intensive Rehabilitation with Perturbation-Based Training
Foot-Intensive Rehabilitation:
Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments. This program will typically include:
- Therapeutic Exercises: Range of motion exercises, strengthening exercises for foot and ankle muscles, proprioceptive training, and flexibility exercises tailored to individual needs.
- Manual Therapy: Hands-on techniques performed by a physical therapist or trained personnel to address soft tissue restrictions, joint mobilization, and mayofascial release.
- Modalities: Use of modalities like ice, heat, ultrasound, or electrical stimulation for pain relief and enhancing tissue healing.
- Functional Training: Specific drills and activities mimicking daily tasks or sports- related movements to improve functional capacity.
Perturbation-Based Training: In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions:
- Balance Challenges: Engaging in exercises on unstable surfaces (e.g., balance boards, foam pads) or using devices inducing controlled instability to challenge balance and neuro- muscular control.
- Dynamic Movements: Performing controlled perturbations or sudden movements to elicit adaptive responses and improve reactive balance strategies.
- Progression: Gradual progression of difficulty and complexity in perturbation-based exercises based on individual tolerance and improvement.
Group B: Foot-Intensive Rehabilitation without Perturbation-Based Training
Foot-Intensive Rehabilitation:
Participants in Group B will receive the same structured rehabilitation program focusing on foot- intensive exercises as in Group A. This program includes similar components such as therapeutic exercises, manual therapy, modalities, and functional training targeting ankle sprain recovery and foot-specific impairments.
Both groups will undergo the assigned interventions for the duration of 6 weeks under the supervision of trained physical therapists or healthcare professionals
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Pakistan Sports Board
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
• Gender: male /female
- Participants aged 18 to 35 years old.
- Diagnosis of an ankle sprain (within 4 weeks of injury).
- No prior history of severe ankle fractures or surgeries(Hoch et al., 2023)
Exclusion Criteria:
- Presence of severe or complex ankle fractures requiring surgical intervention.
- Conditions other than ankle sprain like neuropathy that affect balance or cutaneous sensation.
- Neurological disorders impacting balance or proprioception.
- Pregnancy or planning to become pregnant during the study period(Hoch et al., 2023)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Group A
Foot-Intensive Rehabilitation: Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments |
Foot-Intensive Rehabilitation This program will typically include:
|
|
Sperimentale: Group B
In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions
|
In addition to the foot-intensive rehabilitation program, participants in experimental group will undergo perturbation-based training sessions:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Numeric pain rate scale (NPRS)
Lasso di tempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Patient level of pain will be assessed using this scale.
This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" (Riley et al., 2019)
|
6 weeks (Baseline, 3rd week, 6th week)
|
|
Range of Motion (ROM) Measurement
Lasso di tempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Goniometer: To measure dorsiflexion, plantarflexion, inversion, and eversion of the ankle joint(Rome & Cowieson, 1996).
|
6 weeks (Baseline, 3rd week, 6th week)
|
|
Balance Assessment:
Lasso di tempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Star Excursion Balance Test (SEBT): Measures reach distances in multiple directions to assess dynamic balance and reach symmetry.(Coughlan
et al., 2012)
|
6 weeks (Baseline, 3rd week, 6th week)
|
|
Functional Instability Measurement
Lasso di tempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Cumberland Ankle Instability Tool (CAIT): A questionnaire to assess the severity of functional ankle instability.(ALEXANDRE
et al., 2024)
|
6 weeks (Baseline, 3rd week, 6th week)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sana Akram, MSOMPT, University of Lahore
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UOL/IREB/25/15/03/10
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .