NCT07659522

Brief Summary

This randomized controlled trial aims to investigate the effects of proprioceptive training with and without tibialis anterior strength training in individuals with chronic stroke. Chronic stroke survivors commonly experience impaired balance, gait disturbances, reduced lower-limb muscle strength, and functional limitations that affect mobility and independence. The tibialis anterior muscle plays an important role in ankle dorsiflexion, foot clearance during walking, and postural stability. Participants with chronic stroke will be randomly assigned to one of two intervention groups. One group will receive proprioceptive training combined with tibialis anterior strength training, while the other group will receive proprioceptive training alone. Interventions will be administered over a six-week period. Outcomes related to muscle strength, balance, gait performance, and functional mobility will be assessed at baseline and during follow-up assessments. The study seeks to evaluate rehabilitation approaches targeting lower-limb motor and sensory impairments in individuals with chronic stroke and to contribute evidence regarding interventions designed to improve functional recovery and mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable stroke

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

September 22, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 15, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

BalanceGaitChronic StrokeProprioceptionStrength trainingProprioceptive training

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength of Tibialis Anterior

    Muscle strength will be assessed using a handheld dynamometer (PowerTrack II™ Commander). Participants will perform ankle dorsiflexion against resistance, and the maximum force generated will be recorded in Newtons (N). Higher values indicate greater muscle strength.

    Baseline, Week 3, and Week 6

Secondary Outcomes (3)

  • Balance Performance

    Baseline, Week 3, and Week 6

  • Gait Performance

    Baseline, Week 3, and Week 6

  • Functional Mobility

    Baseline, Week 3, and Week 6

Study Arms (2)

Proprioceptive Training with Strength Training

EXPERIMENTAL

Participants assigned to this group will receive a combination of proprioceptive training and tibialis anterior strength training for six weeks. The proprioceptive training program will include stable surface activities, dynamic balance exercises on an Airex balance surface, and functional mobility tasks designed to challenge postural control and sensory feedback. Strength training will target the tibialis anterior muscle through structured lower-limb exercises and repeated movement practice. Outcome assessments will be conducted at baseline, Week 3, and Week 6.

Procedure: Proprioceptive Training with Tibialis Anterior Strength Training

Proprioceptive Training Alone

ACTIVE COMPARATOR

Participants assigned to this group will receive a proprioceptive training program for six weeks. The intervention will include stable surface balance activities, dynamic balance exercises on an Airex balance surface, and functional mobility tasks aimed at improving proprioception, balance, and movement control. No additional tibialis anterior strength training will be provided. Outcome assessments will be conducted at baseline, Week 3, and Week 6.

Procedure: Proprioceptive Training

Interventions

Participants will receive a six-week rehabilitation program consisting of proprioceptive training combined with tibialis anterior strength training. The proprioceptive training protocol includes three phases: stable surface training, dynamic balance training on an Airex balance surface, and functional mobility exercises. Activities include standing balance tasks, heel raises, single-leg standing, weight-shifting activities, stepping exercises, walking in place, and sit-to-stand transitions. Strength training will target the tibialis anterior muscle through repeated dorsiflexion and lower-limb strengthening exercises performed under therapist supervision. Sessions will be conducted according to the study protocol throughout the intervention period.

Proprioceptive Training with Strength Training

Participants will receive a six-week proprioceptive training program. The intervention consists of three phases: stable surface training, dynamic balance training on an Airex balance surface, and functional mobility exercises. Activities include standing balance tasks with eyes open and closed, heel raises, single-leg standing, stepping exercises, walking in place, weight-shifting activities, and sit-to-stand transitions. The program is designed to improve proprioceptive input, postural control, balance, and functional mobility. No additional tibialis anterior strength training will be provided to this group.

Proprioceptive Training Alone

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residual paresis in the lower extremity (Shahid et al., 2013).
  • Ability to sit unsupported for 30 seconds (Shahid et al., 2013).
  • Ability to follow 3 steps command (Shahid et al., 2013).
  • Least degree of the associated reaction (Shahid et al., 2013).
  • Survivor with stable C.V.S system (Shahid et al., 2013).
  • Survivor without fixed contracture of the lower extremity (Shahid et al., 2013).
  • Participants having a history of stroke within the prior 6 months or more (S. H. Chae et al., 2017).
  • Participants having ability to understand the directions from the researchers (those with a MMSE score of 24 or greater) (S. H. Chae et al., 2017).
  • Patients with grade 1 on modified Ashworth scale (Jan et al., 2019).

You may not qualify if:

  • Presence of acute musculoskeletal symptoms (S. H. Chae et al., 2017).
  • Participants having inability to communicate, and those deemed unable to participate in the study by the researchers (S. H. Chae et al., 2017).
  • Serious cardiac condition (history of the CHF, documented serious and unstable cardiac arrhythmias (Shahid et al., 2013).
  • Hypertrophic cardiomyppathy, severe aortic stenosis, history of severe COPD.
  • Angina and dyspnea at rest or during ADL (Shahid et al., 2013).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (2)

  • Guerrini A, Siotto M, Germanotta M, Cipollini V, Cortellini L, Pavan A, Insalaco S, Khazrai YM, Aprile I. Muscle quality improvement in subacute post-stroke patients after rehabilitation: Usefulness of segmental phase angle from bioelectrical impedance analysis. Clin Nutr. 2024 Jan;43(1):224-231. doi: 10.1016/j.clnu.2023.12.001. Epub 2023 Dec 4.

    PMID: 38096627BACKGROUND
  • Frigo, C. A., Merlo, A., Brambilla, C., & Mazzoli, D. (2023). Balanced foot dorsiflexion requires a coordinated activity of the tibialis anterior and the extensor digitorum longus: a musculoskeletal modelling study. Applied Sciences, 13(13), 7984.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 22, 2026

Study Start

September 22, 2025

Primary Completion

June 14, 2026

Study Completion

June 15, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations