Task Specific Training and Conventional Physical Therapy on Ankle Dorsiflexion in Sub-acute Stroke Patients

NCT ID: NCT07338032

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2026-01-03

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.

Detailed Description

This interventional randomized clinical trial will be conducted over nine months following institutional ethical approval at the University of Lahore Teaching Hospital, Lahore, and Sharif City Medical Hospital. Participants will be recruited using a non-probability purposive sampling technique from the study settings. Eligibility criteria include adults aged 40-65 years with sub-acute stroke (2-6 months post-stroke), ability to walk with or without an assistive device, minimum ankle plantarflexion-dorsiflexion range, ability to follow commands (MMSE ≥24), and plantarflexor spasticity grade 1 or 1+. Key exclusions include uncorrected sensory impairment, neglect, aphasia, painful musculoskeletal conditions, other neurological disorders, and concurrent participation in other rehabilitation programs.

After written informed consent, participants will undergo baseline assessment of functional mobility, balance, and ankle dorsiflexor strength. Randomization will be performed after enrollment using an online randomization tool, with allocation concealment implemented through a sealed-envelope method. This study will use a single-blinded approach in which outcome assessment is conducted by an independent assessor who is not involved in treatment delivery and is unaware of group allocation.

Participants will be allocated to one of two parallel groups:

Group A (Experimental): Task-specific training plus conventional physiotherapy Participants will receive an 8-week program, three sessions per week, approximately 45 minutes per session. Task-specific gait training will include functional walking activities (forward, backward, and sideways walking with appropriate safety guarding and rest intervals). Additional task-oriented lower-limb activities may include toe walking, heel raises on a step, single-leg stance tasks, active toe lifts, and resisted ankle dorsiflexion exercises. Conventional physiotherapy components may be provided alongside task-specific training as per protocol.

Group B (Control): Conventional physiotherapy only Participants will receive an 8-week conventional physiotherapy program, three sessions per week (approximately 45-60 minutes/session), focusing on ankle dorsiflexor strengthening and flexibility. The program will include isometric dorsiflexion against resistance, progressive concentric dorsiflexion strengthening using bands/weights with planned progression, and plantarflexor stretching.

Outcome Measures and Time Points Assessments will be performed at baseline and immediately post-intervention (after 8 weeks). Primary outcomes are (1) ankle dorsiflexor strength assessed by Manual Muscle Testing (MMT) and (2) functional mobility assessed by the Timed Up and Go (TUG) test. Secondary outcome is balance assessed by the Berg Balance Scale (BBS). Data will be analyzed using SPSS with significance level set at p < 0.05.

Sample Size Sample size was calculated using Epitool as 54 participants (27 per group). To account for an anticipated 20% dropout rate, the target enrollment will be 66 participants (33 per group).

Conditions

Stroke; Subacute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Task-Specific Training + Conventional Physiotherapy

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.

Group Type: EXPERIMENTAL

Task-Specific Training Combined With Conventional Physiotherapy

Intervention Type: BEHAVIORAL

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.

Conventional Physiotherapy (Ankle Dorsiflexor Strengthening)

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.

Group Type: OTHER

Conventional Physiotherapy for Ankle Dorsiflexor Strengthening

Intervention Type: BEHAVIORAL

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.

Interventions

Task-Specific Training Combined With Conventional Physiotherapy

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.

Intervention Type: BEHAVIORAL

Conventional Physiotherapy for Ankle Dorsiflexor Strengthening

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Rimsha Khalid

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Lahore Teaching Hospital

Lahore, , Pakistan

Countries

Pakistan

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 39917437 (View on PubMed)

Other Identifiers

UOL/IREB/25/12/0040

Identifier Type: -

Identifier Source: org_study_id