- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Lahore, Pakistan, 54590
- The University of Lahore Teaching Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Muscle Strength of Tibialis Anterior
Délai: 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.
|
Baseline, Week 3, and Week 6
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Balance Performance
Délai: Baseline, Week 3, and Week 6
|
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.
|
Baseline, Week 3, and Week 6
|
|
Gait Performance
Délai: Baseline, Week 3, and Week 6
|
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.
|
Baseline, Week 3, and Week 6
|
|
Functional Mobility
Délai: Baseline, Week 3, and Week 6
|
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.
|
Baseline, Week 3, and Week 6
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UOL/IREB/26/19/01/0013
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .