- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420608
Targeted Ankle Proprioceptive Training Improves Balance, Gait, and Functional Mobility in Chronic Stroke Survivors
Targeted Ankle Proprioceptive Training Improves Balance, Gait, and Functional Mobility in Chronic Stroke Survivors: A Multicenter Randomized Controlled Trial With Longitudinal Follow Up
Study Overview
Status
Intervention / Treatment
Detailed Description
Objectives: Primary: To evaluate the causal effect of 12-week targeted ankle proprioceptive training on weight-bearing ankle proprioception (AMEDA) in chronic stroke survivors.
Secondary: To assess effects on balance (Berg Balance Scale), gait speed (10m walk test), mobility (Timed Up and Go, Functional Ambulation Category), lower extremity motor function (Fugl-Meyer), and sustainability at 6-month follow-up. To describe longitudinal proprioceptive changes in a subsample from acute to chronic stages.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Peshawar
-
Swāt, Peshawar, Pakistan
- Iqra National University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of chronic ischemic/hemorrhagic stroke (≥12 months post-stroke)
- Moderate-to-severe lower extremity impairment (Fugl-Meyer LE ≤28 or NIHSS motor leg ≥2)
- Documented ankle proprioceptive deficit (AMEDA AUC <0.7)
Exclusion Criteria:
- Acute medical issues (e.g., uncontrolled hypertension)
- Severe cognitive impairment (MMSE <24)
- Exercise contraindications
- Concurrent conflicting trials
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 |
|---|---|
|
Active Comparator: Phase 1 (Weeks 1-4)
Robotic-assisted sensory discrimination (inversion/eversion, plantar/dorsiflexion; reduce angles, remove visual feedback).
|
Both groups: 12 weeks, 3 sessions/week × 60 min, supervised.
Intervention Group (n=70): Progressive targeted ankle proprioceptive training
|
|
Active Comparator: Phase 2 (Weeks 5-8)
Functional weight-bearing challenges (e.g., balance boards, textured surfaces, dynamic tasks).
|
Both groups: 12 weeks, 3 sessions/week × 60 min, supervised.
Intervention Group (n=70): Progressive targeted ankle proprioceptive training
|
|
Active Comparator: Phase 3 (Weeks 9-12)
Advanced integration (e.g., gait with proprioceptive cues, dual task)
|
Both groups: 12 weeks, 3 sessions/week × 60 min, supervised.
Intervention Group (n=70): Progressive targeted ankle proprioceptive training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcome
Time Frame: post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.
|
Active Movement Extent Discrimination Apparatus for measuring propioceptive acuity
|
post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary outcome
Time Frame: post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.
|
Berg Balance Scale for assessment of static balance and fall risk.
|
post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayman Abdullah Alhammad, Taibah University
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ref#: INU/REHAB/XC94
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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