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

NCT05173389 | Unknown DMC

• 1 other identifier: ıstanbulıucnazıye
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Chronic Stroke

Keywords

stroke, paresis, postural balance

Outcome Measures

Primary Outcomes (1)

• "Single Leg Stance Test (SLST)"

  For the test, volunteers were asked to lift one foot without touching the support leg, look steadily across, and maintain their balance for 30 seconds. The time they focused on the paretic limb for hemiparetic individuals and the time they focused on the dominant limbs for healthy individuals were recorded.

  Balance was evaluated first time at baseline, rehabilitation program, and second time after 4 weeksrehabilitation, change was evaluated

Secondary Outcomes (2)

• "Berg Balance Scale (BBS)"

  Balance was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated

• "Techno Body" Balance Test

  Balance was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated

Other Outcomes (3)

• "PostureScreen Mobile"

  Posture was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated

• "Timed up&go test"

  Functionallity was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated

• Daily Life Activities: Functional Independence Measures (FIM)

  Daily activities, was evaluated first time at baseline, rehabilitation program, and second time after 4 weeks rehabilitation, change was evaluated

Study Arms (2)

Group 1

OTHER

TechnoBody

Other: TechnoBody

Group 2

OTHER

Thera Trainer

Other: Thera-Trainer

Interventions

TechnoBody OTHER

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

Group 1

Thera-Trainer OTHER

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

Group 2

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University Cerrapasa

Istanbul, Alkent 2000, 34500 Büyükçekmece/İstanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naziye Şenyuva Ceyhan, MscPt

  Istanbul University Cerrapasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Prospective Paralel Group Comparison Study

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 29, 2021
• Study Start: April 1, 2020
• Primary Completion: December 20, 2023
• Study Completion: December 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

TU (1)