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Stroke is a leading cause of long-term disability, with balance and gait deficits affecting >80% of survivors and increasing fall risk. Emerging evidence links ankle proprioceptive impairment-particularly inversion/eversion acuity-to these deficits, often bilateral and central in origin. Cross-sectional studies show strong associations, but causality, temporal progression, and intervention efficacy (especially in severe/non-ambulatory cases) remain unproven. This trial tests a targeted proprioceptive protocol against standard care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (Weeks 1-4) | Active Comparator | Robotic-assisted sensory discrimination (inversion/eversion, plantar/dorsiflexion; reduce angles, remove visual feedback). |
|
| Phase 2 (Weeks 5-8) | Active Comparator | Functional weight-bearing challenges (e.g., balance boards, textured surfaces, dynamic tasks). |
|
| Phase 3 (Weeks 9-12) | Active Comparator | Advanced integration (e.g., gait with proprioceptive cues, dual task) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait training | Other | Both groups: 12 weeks, 3 sessions/week × 60 min, supervised. Intervention Group (n=70): Progressive targeted ankle proprioceptive training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Abdullah Alhammad | Taibah University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IQRA National University | Swāt | Peshawar | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42216149 | Derived | Khan M, Alhammad AA, Alghadier M, Alnasser SM, Alanazi AB, AlAidarous HAA, Moustafa EBS, Sharahily MA, Amri MI, Muteesasira E. Targeted ankle proprioceptive training improves balance, gait, and functional mobility in chronic stroke survivors: a multicenter randomized controlled trial with longitudinal follow-up. J Neuroeng Rehabil. 2026 May 29. doi: 10.1186/s12984-026-02031-5. Online ahead of print. |
| Label | URL |
|---|---|
| data set | View source |
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Ethical concerns underlying data sharing will be adhered too
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 31, 2022 | Feb 11, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Multicenter, parallel-group, randomized controlled trial (RCT) with 1:1 allocation, assessor-blinded, intention-to-treat analysis. Includes a longitudinal observational subsample for acute-to-chronic proprioceptive changes.
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |