Clinical trial NCT05173389: Comparison Effects of Two Different Balance Systems on the Balance, Posture and Functionality in Stroke Patients
Official title: Comparison Effects of Two Different Balance Systems on the Balance, Posture and Functionality in Stroke Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Stroke
Keywords: stroke, paresis, postural balance
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 41
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Paralel Group Comparison Study
Primary purpose: OTHER

Brief 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)

Eligibility criteria: Inclusion Criteria:

* Having a hemiparesis due to stroke
* At least 6 months have passed since the stroke
* To cooperate,
* No visual problems
* Scoring of Mini Mental test 18-23
* Can walk with auxiliary device or completely independently
* Robust side can stand at least 30 seconds in one leg balance
* Patients walking independently 10 meter with or without any assistive walking device

Exclusion Criteria:

* Contracture in hemiparetic side limb joints
* Accompanying lower motor neuron disease or peripheral nerve lesion
* Presence of other neurological disorders such as accompanying ataxia, dystonia, dyskinesia
* An important comorbid disease that may prevent rehabilitation such as serious heart disease (aortic stenosis, angina, arrhythmia, pacemaker) and uncontrolled hypertension
* Having vision problems

Primary outcomes:
measure: "Single Leg Stance Test (SLST)"
timeFrame: Balance was evaluated first time at baseline, rehabilitation program, and second time after 4 weeksrehabilitation, change was evaluated
Secondary outcomes:
measure: "Berg Balance Scale (BBS)"
timeFrame: Balance was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated
measure: "Techno Body" Balance Test
timeFrame: Balance was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated
Other outcomes:
measure: "PostureScreen Mobile"
timeFrame: Posture was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated
measure: "Timed up&go test"
timeFrame: Functionallity was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated
measure: Daily Life Activities: Functional Independence Measures (FIM)
timeFrame: Daily activities, was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University Cerrapasa
state: Alkent 2000, 34500 Büyükçekmece/İstanbul
Study officials:
affiliation: Istanbul University Cerrapasa
name: Naziye Şenyuva Ceyhan, MscPt
role: PRINCIPAL_INVESTIGATOR
References: