- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07578779
Effects of Frenkels Exercises and Electrical Muscle Stimulation on Stroke Patients
Combined Effects of Frenkels Exercises and Electrical Muscle Stimulation on Balance, Coordination and Proprioception in Stroke Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Imran Amjad, Phd
- Numero di telefono: 03324390215
- Email: imranamjad@riphah.edu.pk
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Typically 50-65 years old.(14)
- Both male and female are included
- Patients with subacute ischemic stroke (hemiplegia).(15)
- Ability to walk independently for at least 10minutes.(16)
- Diagnosis of a first-time stroke or without sequel of a previous stroke(15)
- MOCA score>26 to confirm adequate cognitive function.
- Brunnstrom exercise recovery stages of 3-4 or higher(17)
- Voluntarily provided informed consent prior to participating
Exclusion Criteria:
- Patients with severe cognitive impairment or dementia.(16)
- Patients with unstable medical conditions, such as uncontrolled hypertension or cardiac disease.
- Patients with recent surgery or injury that may affect participation in the study.
- Patients with contraindications to electrical muscle stimulation (EMS), such as unstable cardiopulmonary medical conditions pacemakers or metal implants
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: Frenkels exercise with EMS
Participant will receive EMS for 10 minutes and Frenkels exercise for 20 minutes for 3 days per week for 8 weeks
|
Group A will include 19 participants.
Each participant will receive EMS for 10 minutes and Frenkels exercise for 20 minutes for 3 days per week for 8 weeks In Week 1-2 we will apply 50 Hz EMS pulse duration of 150 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest stimulation for adaptation while focusing lower limb exercises in according to frenkles exercises for 20 min in lying position Week 3-4: 60 Hz EMS stimulation will be applied pulse duration of 200 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest with frenkles exercises in sitting position Week 5-6 Frequency of 70 Hz pulse duration of 250 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest EMS stimulation will be applied with frenkles exercises in standing position Week 7-8: In progression, Frequency of 85 Hz and pulse duration of 300 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest
|
|
Comparatore attivo: Conservative Treatment
Participants will receive routine therapy for 30 minutes.
It could be hot pack, IR with routine exercises for 3 days per week for 8 weeks.
|
Group B will also include 19 participants. Each participant will receive routine therapy for 30 minutes. It could be hot pack, IR with routine exercises for 3 days per week for 8 weeks. Weeks 1-2: Initial Phase
b) Weight-bearing exercises c) Gait training: Walking with support d) Balance exercises: Weeks 5-6 Functional Phase
Weeks 7-8: Advanced Phase
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The Berg Balance Scale (BBS)
Lasso di tempo: Baseline and 8th week
|
It's a 14-item performance-based measure, meaning it assesses how well a person can perform specific tasks related to balance.
Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance, and a total score range of 0-56.
|
Baseline and 8th week
|
|
The Nottingham Sensory Assessment (NSA)
Lasso di tempo: baseline and 8th week
|
NSA is used to evaluate sensory impairments, particularly in individuals who have experienced stroke. scores ranging from 0 (extreme difficulty/unable to perform) to 4 (no difficulty) for each item. |
baseline and 8th week
|
|
The Lower Extremity Motor Coordination Test (LEMOCOT)
Lasso di tempo: Baseline and 8th Week
|
(LEMOCOT) scoring scale involves assessing an individual's ability to perform specific lower extremity movements, with scores ranging from 0 (extreme difficulty/unable to perform) to 4 (no difficulty) for each item.
The total score is obtained by summing the scores of all items, with a higher score indicating better motor coordination.
|
Baseline and 8th Week
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sabiha Arshad, Riphah International University
Pubblicazioni e link utili
Pubblicazioni generali
- 1. Ko EJ, Chun MH, Kim D-Y, Kang Y, Lee SJ, Yi JH, et al. Frenkel's exercise on lower limb sensation and balance in subacute ischemic stroke patients with impaired proprioception. Neurology Asia. 2018;23(3).
- Shoeb M, Mishra A, Yadav KK, Kumar S, Yadav S. Effect of BAPS Board Versus Frenkel Exercise on Balance in Stroke Patient's-A Pilot Study.
- Haque S. Effectiveness of frankel exercise to improve balance and function after stroke: Bangladesh Health Professions Institute, Faculty of Medicine, the University …; 2023.
- Khan S, Shahid W, Khalid R, Pervez M, Hameed R, Khaliq S. Effects of Proprioceptive Neuromuscular Facilitation with and without Electrical Muscle Stimulation on spasticity, gait and lower limb function in chronic stroke patients. Journal of Health and Rehabilitation Research. 2024;4(3):1-6.
- Arif A, Arshad K, Tariq S, Sundas S, Tariq N, Kabir A, et al. COMPARATIVE EFFECTS OF VIRTUAL REALITY AND FRENKEL'S EXERCISES ON BALANCE, GAIT AND QUALITY OF LIFE IN PATIENTS WITH STROKE. Insights-Journal of Health and Rehabilitation. 2024;2(2 (Health & Rehab)):459-67.
- Yoo HJ, Park S, Oh S, Kang M, Seo Y, Kim BG, Lee SH. Effects of electrical muscle stimulation on core muscle activation and physical performance in non-athletic adults: A randomized controlled trial. Medicine (Baltimore). 2023 Jan 27;102(4):e32765. doi: 10.1097/MD.0000000000032765.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
- REC/0218 Waneeza Malik
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 .