NCT07655973

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 30, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

June 13, 2026

Last Update Submit

June 28, 2026

Conditions

Keywords

Foot PerturbationFoot Intensive RehabilitationAnkle Sprain

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rate scale (NPRS)

    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

    Goniometer: To measure dorsiflexion, plantarflexion, inversion, and eversion of the ankle joint(Rome \& Cowieson, 1996).

    6 weeks (Baseline, 3rd week, 6th week)

  • Balance Assessment:

    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

    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)

Study Arms (2)

Foot-Intensive Rehabilitation

ACTIVE COMPARATOR

Foot-Intensive Rehabilitation: Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments

Other: Foot-Intensive Rehabilitation

Foot-Intensive Rehabilitation + Perturbation-Based Training

EXPERIMENTAL

In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions

Other: Foot-Intensive Rehabilitation + Perturbation-Based Training

Interventions

Foot-Intensive Rehabilitation 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.

Foot-Intensive Rehabilitation

In addition to the foot-intensive rehabilitation program, participants in experimental group 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.

Foot-Intensive Rehabilitation + Perturbation-Based Training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Sports Board

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Sana Akram, MSOMPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 18, 2026

Study Start

December 27, 2025

Primary Completion

March 12, 2026

Study Completion

April 27, 2026

Last Updated

June 30, 2026

Record last verified: 2025-12

Locations