- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07659522
Proprioceptive Training With or Without Strength Training on Tibialis Anterior in Chronic Stroke Patients
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.
Study Overview
Status
Conditions
Detailed Description
Stroke is a major cause of long-term disability worldwide and is frequently associated with persistent motor and sensory impairments. Individuals living with chronic stroke often experience reduced muscle strength, impaired proprioception, balance deficits, gait abnormalities, and decreased functional mobility. These impairments can limit participation in daily activities and reduce overall quality of life.
The tibialis anterior muscle is an important component of lower-limb function because it contributes to ankle dorsiflexion during gait and assists with postural control. Weakness of this muscle following stroke may contribute to foot drop, reduced walking efficiency, impaired balance, and an increased risk of falls. Rehabilitation strategies that target both sensory and motor impairments may support recovery of lower-extremity function.
Proprioception refers to the ability to perceive joint position and movement through sensory input from muscles, tendons, and joints. Following stroke, disruption of sensory pathways may impair proprioceptive function and negatively affect motor performance. Proprioceptive training is commonly used in rehabilitation programs to improve sensory awareness, postural control, coordination, and movement quality through structured balance and functional activities.
Strength training is another established rehabilitation intervention used to address muscle weakness after stroke. Targeted strengthening exercises may improve force generation, neuromuscular activation, and lower-extremity performance during functional tasks. Strengthening the tibialis anterior muscle may assist with ankle control and walking-related activities.
This study will use a randomized controlled trial design. Participants diagnosed with chronic stroke who meet the eligibility criteria will be recruited from the University of Lahore Teaching Hospital. Following informed consent and baseline assessment, participants will be randomly allocated to one of two groups:
Group A: Proprioceptive training combined with tibialis anterior strength training.
Group B: Proprioceptive training alone.
The intervention period will last six weeks. Assessments will be conducted at baseline, Week 3, and Week 6. Outcome measures will evaluate lower-limb muscle strength, balance performance, gait characteristics, and functional mobility.
The study is designed to examine rehabilitation approaches commonly used in neurological physical therapy and to provide information regarding their application in individuals with chronic stroke. The findings may help guide future rehabilitation programs aimed at improving lower-extremity function, mobility, and participation in daily activities among stroke survivors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lahore, Pakistan, 54590
- The University of Lahore Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Proprioceptive Training with Strength Training
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.
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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.
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Active Comparator: Proprioceptive Training Alone
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle Strength of Tibialis Anterior
Time Frame: Baseline, Week 3, and Week 6
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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.
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Baseline, Week 3, and Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Balance Performance
Time Frame: Baseline, Week 3, and Week 6
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Balance performance will be evaluated using the Berg Balance Scale (BBS), a 14-item clinical assessment that measures static and dynamic balance.
Scores range from 0 to 56, with higher scores indicating better balance performance.
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Baseline, Week 3, and Week 6
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Gait Performance
Time Frame: Baseline, Week 3, and Week 6
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Gait performance will be assessed using the Wisconsin Gait Scale, which evaluates gait characteristics including speed, symmetry, and movement quality.
Higher scores indicate improved gait performance.
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Baseline, Week 3, and Week 6
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Functional Mobility
Time Frame: Baseline, Week 3, and Week 6
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Functional mobility will be measured using the Timed Up and Go (TUG) Test.
Participants will be timed while standing from a chair, walking three meters, turning, returning, and sitting down.
Lower completion times indicate better functional mobility.
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Baseline, Week 3, and Week 6
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/26/19/01/0013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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