NCT07338032

Brief Summary

This study is a randomized clinical trial designed to compare two physiotherapy rehabilitation approaches for people in the sub-acute phase after stroke (2-6 months after stroke). Stroke often causes weakness of the ankle dorsiflexor muscles, which can lead to foot drop and difficulty walking safely. Improving ankle control may help balance and functional mobility. Eligible participants will be recruited from two tertiary care hospitals using purposive sampling and enrolled after providing informed consent. After baseline assessment, participants will be randomly allocated to one of two groups. The experimental group will receive task-specific training combined with conventional physiotherapy, and the control group will receive conventional physiotherapy alone. Treatment will be delivered for 8 weeks, three sessions per week. Outcomes will be assessed at baseline and after completion of the 8-week intervention. The primary outcomes are ankle dorsiflexor strength measured by Manual Muscle Testing (MMT) and functional mobility measured by the Timed Up and Go (TUG) test. Balance measured by the Berg Balance Scale (BBS) is the secondary outcome. An independent outcome assessor who is not involved in treatment delivery will conduct the assessments to reduce measurement bias.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 3, 2026

Last Update Submit

January 3, 2026

Conditions

Keywords

Ankle DorsiflexionGaitStroke RehabilitationTask-Specific TrainingTime Up and Go Test

Outcome Measures

Primary Outcomes (2)

  • Ankle Dorsiflexor Muscle Strength

    Ankle dorsiflexor muscle strength will be assessed using Manual Muscle Testing (MMT). Muscle strength is graded on a standardized ordinal scale ranging from 0 (no visible or palpable muscle contraction) to 5 (normal muscle strength against full resistance). MMT will be performed by a trained assessor using standardized positioning and resistance techniques to ensure consistency. The assessment focuses on the affected lower limb ankle dorsiflexor muscles, which are essential for foot clearance and gait during walking.

    Baseline (pre-intervention) and immediately after completion of the 8-week intervention program

  • Functional Mobility Assessed by the Timed Up and Go Test

    Functional mobility will be evaluated using the Timed Up and Go (TUG) test. The test measures the time, in seconds, required for a participant to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. Lower completion times indicate better functional mobility. The TUG test will be administered under standardized conditions by a trained assessor to ensure reliability and reproducibility.

    Baseline (pre-intervention) and immediately after completion of the 8-week intervention program

Secondary Outcomes (1)

  • Balance Assessed by the Berg Balance Scale

    Baseline (pre-intervention) and immediately after completion of the 8-week intervention program

Study Arms (2)

Task-Specific Training + Conventional Physiotherapy

EXPERIMENTAL

Participants will receive an 8-week program (3 sessions/week; \~45 min/session) consisting of task-specific gait and ankle-focused functional activities combined with conventional physiotherapy. Task-specific training includes goal-directed walking tasks (forward, backward, and sideways walking with therapist guarding; structured sets and rest). Additional task-oriented exercises may include toe walking, heel raises on a step, single-leg stance on a foam surface, active toe lifts, and resisted ankle dorsiflexion using weighted boots or resistance bands. Conventional components (as per protocol) may be provided alongside to support strength, flexibility, and safe gait practice.

Behavioral: Task-Specific Training Combined With Conventional Physiotherapy

Conventional Physiotherapy (Ankle Dorsiflexor Strengthening)

OTHER

Participants will receive conventional physiotherapy for 8 weeks (3 sessions/week; \~45-60 min/session) focusing on ankle dorsiflexor strengthening and flexibility. The strengthening program includes isometric ankle dorsiflexion against manual resistance (held contractions with rest intervals, repeated in sets) and progressive concentric dorsiflexion strengthening using resistance bands or ankle weights with gradual progression in intensity and repetitions across the intervention period. Plantarflexor stretching will be performed as part of the protocol (held stretches repeated per session). The program is delivered by an experienced physiotherapist under standardized safety and positioning instructions.

Behavioral: Conventional Physiotherapy for Ankle Dorsiflexor Strengthening

Interventions

This intervention consists of a conventional physiotherapy program focused on ankle dorsiflexor strengthening and flexibility, delivered over 8 weeks with three supervised sessions per week (45-60 minutes per session). The program includes isometric ankle dorsiflexion exercises against manual resistance, held contractions with rest intervals, and progressive concentric dorsiflexion strengthening using resistance bands or ankle weights with gradual increases in intensity and repetitions. Passive and active stretching of the plantarflexor muscles is also included. All exercises are administered by an experienced physiotherapist using standardized positioning, safety precautions, and progression criteria.

Conventional Physiotherapy (Ankle Dorsiflexor Strengthening)

This intervention consists of task-specific training combined with conventional physiotherapy delivered over 8 weeks, with three supervised sessions per week (approximately 45 minutes per session). Task-specific training emphasizes repetitive, goal-directed functional activities designed to enhance ankle dorsiflexion during gait. Exercises include forward, backward, and sideways walking under therapist supervision, toe walking, heel raises on a step, single-leg stance tasks, active toe lifts, and resisted ankle dorsiflexion using weighted boots or resistance bands. Conventional physiotherapy components, including strengthening and flexibility exercises for the ankle dorsiflexors, may be incorporated alongside task-oriented activities as per protocol. All sessions are delivered by a qualified physiotherapist following standardized safety and progression guidelines.

Task-Specific Training + Conventional Physiotherapy

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Onset of stroke 2-6 months before study enrollment (Van Criekinge et al., 2022).
  • Ability to walk with or without an assistive device (Khallaf, 2020).
  • Presence of a minimum of 8-10 Degree of ankle plantarflexion-dorsiflexion range
  • Ability to follow a three-step command, MMSE 24 (Srivastava et al., 2024).
  • Spasticity of plantarflexers 1 or 1+ (Abd Elsabour et al., 2025).
  • Not participating in any other form of physical rehabilitation. No lumber radiculopathy (Srivastava et al., 2024).

You may not qualify if:

  • Uncorrected vision and hearing loss or sensory impairment (Van Criekinge et al., 2022).
  • Unilateral or Visual neglect (Van Criekinge et al., 2022).
  • Sensory or global aphasia (Khallaf, 2020).
  • Pain or musculoskeletal or any other neurological disorder (Srivastava et al., 2024).
  • Carcinoma (Srivastava et al., 2024).

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)

  • Dorsch, S., Ada, L., Canning, C. G., & Al-Zoubi, F. (2023). Bobath therapy is inferior to task-specific training and not superior to usual care after stroke: A systematic review. Journal of NeuroEngineering and Rehabilitation, 20, 12. https://doi.org/10.1186/s12984-023-01154-6

    BACKGROUND
  • Belghith K, Zidi M, Vincent L, Fedele JM, Bou-Serhal R, Maktouf W. Eccentric strengthening vs. conventional therapy in sub-acute stroke survivors: a randomized controlled trial. Front Neurol. 2025 Jan 23;15:1398860. doi: 10.3389/fneur.2024.1398860. eCollection 2024.

    PMID: 39917437BACKGROUND

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

January 3, 2026

First Posted

January 13, 2026

Study Start

June 16, 2025

Primary Completion

December 29, 2025

Study Completion

January 3, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations