Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients

Istanbul University - Cerrahpasa (IUC)

Status: Invitation-only

Conditions: Robotic Exoskeleton; Stroke; Stroke Rehabilitation

Treatments: Other: Combined RAGT and TBT; Other: balance exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05447754

2022/18

Details and patient eligibility

About

In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being 18 years or older
• Volunteering to participate in the study
• Having been diagnosed with stroke (at least 3 months)
• Age range 18 ≥ or 75 <
• Being able to walk independently (Functional Ambulation Scale> 3)
• Modified Ashworth Scale ≤ 2 spasticity value

Exclusion criteria

• Being under the age of 18
• Having severe visual and cognitive impairment
• Having severe cardiovascular disease
• Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
• Being involved in a robotic rehabilitation program before

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Combined RAGT and TBT

Experimental group

Description:

Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises.

Treatment:

Other: Combined RAGT and TBT

TBT Only

Active Comparator group

Description:

Participants were given balance exercises (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing without an assistive device, walking on a flat surface to the forward and sideways) for 5 weeks, 5 times a week and for 40 minutes in each session. lying down while sitting and standing) will be applied.

Treatment:

Other: balance exercises