StrokeNCT07659522
Proprioceptive Training With or Without Strength Training on Tibialis Anterior in Chronic Stroke Patients
A study testing Proprioceptive Training with Tibialis Anterior Strength Training and Proprioceptive Training in people with Stroke, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Proprioceptive Training with Tibialis Anterior Strength Training and Proprioceptive Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Proprioceptive Training with Tibialis Anterior Strength Training, Proprioceptive Training
- Keywords
- Balance, Gait, Chronic Stroke, Proprioception, Strength training, Proprioceptive training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Training with Tibialis Anterior Strength TrainingProcedure or surgery
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 TrainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Proprioceptive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 3, and Week 6
Secondary outcomes (3)
Balance Performance
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.
Measured: Baseline, Week 3, and Week 6
Gait Performance
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.
Measured: Baseline, Week 3, and Week 6
Functional Mobility
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.
Measured: Baseline, Week 3, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start22 Sep 2025
- Primary completion14 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maham Asghar, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659522
- Sponsor's protocol ID
- UOL/IREB/26/19/01/0013
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38096627Frigo, 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 at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Training With or Without Strength Training on Tibialis Anterior in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07659522
- Acronym / sponsor ID
- UOL/IREB/26/19/01/0013
- Conditions
- Stroke
- Keywords
- Balance, Gait, Chronic Stroke, Proprioception, Strength training, Proprioceptive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Training with Strength Training | Experimental | Procedure: Proprioceptive Training with Tibialis Anterior Strength TrainingParticipants 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. |
| Proprioceptive Training Alone | Active comparator | Procedure: Proprioceptive TrainingParticipants 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Training with Tibialis Anterior Strength TrainingParticipants 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. | Procedure or surgery | Proprioceptive Training with Strength Training |
| Proprioceptive TrainingParticipants 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. | Procedure or surgery | Proprioceptive Training Alone |
Primary outcome
Muscle Strength of Tibialis Anterior
Time frame: Baseline, Week 3, and Week 6
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.
3 secondary outcomes
Balance Performance
Time frame: Baseline, Week 3, and Week 6
Gait Performance
Time frame: Baseline, Week 3, and Week 6
Functional Mobility
Time frame: Baseline, Week 3, and Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 38096627Guerrini 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.
- BackgroundFrigo, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Training with Tibialis Anterior Strength Training and Proprioceptive Training in people with Stroke, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength of Tibialis Anterior (time frame: Baseline, Week 3, and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07659522, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.