NCT05173389

Comparison Effects of Two Different Balance Systems on the Balance, Posture and Functionality in Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Study will include 2 different groups intervention. First group, chronic stroke patients: Bobath Method 30 minutes, 10 minutes bicycle exercises, NMES- (Neuromuscular electrical stimulation) will be applied to the hemiparetic limb 10 minutes, TechnoBody balance training 15 minutes in the same session. Second group chronic stroke patients: Bobath Method 30 minutes, 10 minutes bicycle exercises Nmes- (Neuromuscular electrical stimulation) will be applied hemiparetic limb 10 minutes and Thera-Trainer balance training 15 minutes in the same session. Study Aim: İnvestigate and compare the effects of "Techno Body" and "Balance Trainer" on the balance, posture and functionality in patients with chronic stroke in order to bring a new perspective conventional physiotherapy and rehabilitation studies. Study will be an important study in terms of the literature ,effects two technology-supported balance systems will be revealed and compared in stroke patients order to improve balance, posture and functionality. Study Hypothesis: 1. \- Effects of two different balance systems on balance, posture and functionality are compared in stroke patients; No difference between balance training with TechnoBody device and balance training with Theratrainer device. 2. \- Effects of two different balance systems on balance, posture and functionality compared in stroke patients; Difference between balance training with TechnoBody device and balance training with Theratrainer device. Conclusion: Effects of two technology-supported balance systems will be improve balance, posture and functionality in stroke patients and balance sistems advantages will be compared.

Detailed description

Study was planned in the Erenköy Physical Therapy and Rehabilitation Hospital on 41 patients with stroke-related hemiparesis. Randomized double blinded study and the power analysis was calculated with the PS-Power Sample Size Calculator considering "Single Leg Stance Test (SLST)" score, primary result measurements. Patients was determined as "Informed Consent Form" will be signed regarding the evaluations to be made, treatments to be applied, gains after treatment and risks that may be encountered during treatments before study, and participate in study voluntarily. Patients in groups will be evaluated before and after treatment following methods. - Demographic and disease-specific clinical evaluation form: Personal and disease information of patients will be collected with a patient follow-up form. While personal information section of patient follow-up form includes the name-surname, age, gender, height, weight, smoking-alcohol use, occupation, education and marital status. information about the disease, information about stroke, assistive device used, treatments date. Systemic disease finding, drugs currently used, and history of disease onset and development Balance assessment- "Berg Balance Scale (BBS)", "Functional Reach Test", "Trunk Impairment Scale ", "Single Leg Stance Test (SLST)" and "TechnoBody" device will be performed. . Posture evaluation - to be done with "PostureScreen Mobile" Functionality assessment: -" Time Up-Go Test", "30 - second Chair Stand Test". Mental condition: Standardized Mini Mental Test (SMMT) Daily Life Activities: Functional Independence Measures (FIM) will be evaluated. First group will be included, balance program with "TechnoBody" device. Second group will be taken balance program with "Thera-Trainer" device. Results of both groups will be compared after 4 weeks. Both groups will be applied 5 days of week 1. Exercise bike with visual feedback, which allows active-assisted or resistant work according to condition patient, will be done in lower limb for 10 minutes. 2. Nmes- (Neuromuscular electrical stimulation) will be applied to hemiparetic limb for 10 minutes. 3. Bobath Method- 30 minutes 4. First Group-TechnoBody balance training (15 min / 5 days a week, 4 weeks) Second Group-Thera-Trainer balance training (15 min / 5 days a week, 4 weeks)

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
OTHER	TechnoBody	1\. Group-TechnoBody balance training (15 min / 5 days a week, 4 weeks) In the study, the first group will be included in the balance program with the "TechnoBody" device Patients will be applied 5 days of week 1. Exercise bike with visual feedback, which allows active-assisted or resistant work according to the condition of the patient, will be done in the lower limb for 10 minutes. 2. Nmes- (Neuromuscular electrical stimulation) will be applied to the hemiparetic limb for 10 minutes. 3. Bobath Method- 30 minutes
OTHER	Thera-Trainer	2\. Group-Thera-Trainer balance training (15 min / 5 days a week, 4 weeks) the second group will be taken into the balance program with the "Thera-Trainer" device and the results of both groups will be compared after 4 weeks. Patients will be applied 5 days of week 1. Exercise bike with visual feedback, which allows active-assisted or resistant work according to the condition of the patient, will be done in the lower limb for 10 minutes. 2. Nmes- (Neuromuscular electrical stimulation) will be applied to the hemiparetic limb for 10 minutes. 3. Bobath Method- 30 minutes

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-12-20
• Completion: 2023-12-30
• First posted: 2021-12-29
• Last updated: 2023-10-03

Locations

1 site across 1 country: Turkey (Türkiye)