NCT07420608

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 4, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

strokestroke sequelae

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Secondary outcome

    post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.

Study Arms (3)

Phase 1 (Weeks 1-4)

ACTIVE COMPARATOR

Robotic-assisted sensory discrimination (inversion/eversion, plantar/dorsiflexion; reduce angles, remove visual feedback).

Other: Gait training

Phase 2 (Weeks 5-8)

ACTIVE COMPARATOR

Functional weight-bearing challenges (e.g., balance boards, textured surfaces, dynamic tasks).

Other: Gait training

Phase 3 (Weeks 9-12)

ACTIVE COMPARATOR

Advanced integration (e.g., gait with proprioceptive cues, dual task)

Other: Gait training

Interventions

Both groups: 12 weeks, 3 sessions/week × 60 min, supervised. Intervention Group (n=70): Progressive targeted ankle proprioceptive training

Phase 1 (Weeks 1-4)Phase 2 (Weeks 5-8)Phase 3 (Weeks 9-12)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Acute medical issues (e.g., uncontrolled hypertension)
  • Severe cognitive impairment (MMSE \<24)
  • Exercise contraindications
  • Concurrent conflicting trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IQRA National University

Swāt, Peshawar, Pakistan

Location

Related Links

MeSH Terms

Conditions

Somatosensory DisordersStroke

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ayman Abdullah Alhammad

    Taibah University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 19, 2026

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Ethical concerns underlying data sharing will be adhered too

Locations