- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Imran Amjad, Phd
- Telefonnummer: 03324390215
- E-post: imranamjad@riphah.edu.pk
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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 Investigator will apply 50Hz EMS pulse duration of 150 μs, intermittent with 5s of EMS stimulation to perform the movement and 10s 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 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
|
|
Aktiv komparator: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Berg Balance Scale (BBS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sabiha Arshad, M.Phill, Riphah International University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REC/0218 Waneeza Malik
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