- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Lahore, Pakistan, 54590
- The University of Lahore Teaching Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Muscle Strength of Tibialis Anterior
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Balance Performance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UOL/IREB/26/19/01/0013
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .