- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Pakistan Sports Board
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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:
|
|
Experimental: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rate scale (NPRS)
Time Frame: 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)
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6 weeks (Baseline, 3rd week, 6th week)
|
|
Range of Motion (ROM) Measurement
Time Frame: 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:
Time Frame: 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)
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6 weeks (Baseline, 3rd week, 6th week)
|
|
Functional Instability Measurement
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sana Akram, MSOMPT, University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/25/15/03/10
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 Ankle Sprain
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University of LahoreCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Lateral Ankle SprainPakistan
-
Decathlon SEEFOR, FranceTerminatedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeFrance
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Université Catholique de LouvainCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd DegreeBelgium
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Instituto Mexicano del Seguro SocialCompletedAnkle Sprain | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeMexico
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