Task Specific Training and Conventional Physical Therapy on Ankle Dorsiflexion in Sub-acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Ankle Dorsiflexor Muscle Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Task-Specific Training Combined With Conventional Physiotherapy (Behavioral)
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.
干预措施: Conventional Physiotherapy for Ankle Dorsiflexor Strengthening (Behavioral)
结局指标
主要结局
Ankle Dorsiflexor Muscle Strength
时间窗: Baseline (pre-intervention) and immediately after completion of the 8-week intervention program
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.
Functional Mobility Assessed by the Timed Up and Go Test
时间窗: Baseline (pre-intervention) and immediately after completion of the 8-week intervention program
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.
次要结局
- Balance Assessed by the Berg Balance Scale(Baseline (pre-intervention) and immediately after completion of the 8-week intervention program)
研究者
Rimsha Khalid
Student
University of Lahore