Virtual Reality Based Robotic Gait and Balance Trainer

Stroke Clinical Trial

Official title:

A Comparison of the Effects of Virtual Reality-Based Balance Training and Robot-Assisted Gait Training on Balance and Gait Performance in Individuals With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164197
• Other study ID #: RAGT03
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of research is to examine and compare the effectiveness of virtual reality-based balance training and robot-assisted walking approaches on balance and gait in individuals post-stroke. Through the study, Investigators intend to reach conclusions regarding whether the focus should be on balance or walking training based on the Berg Balance Scale and Functional Ambulation Classification levels of stroke survivors. Subgroups will be formed in both groups based on Functional Ambulation and Berg Balance Scale scores. The balance and gait developments within these subgroups will be compared, aiming to determine at which levels balance or walking improvement is more pronounced. These findings are crucial for making the right choices in setting rehabilitation goals for individual patients.

Description:

Stroke is one of the leading causes of death in adults and results in severe disability. Within the first 3 months after a stroke, 20% of patients use a wheelchair, and 70% experience walking problems. Balance problems are among the most common issues after a stroke, impacting a patient's ability to sit, stand, transfer, and walk, thereby creating a risk of falls. Additionally, balance and walking quality are vital components, with abnormalities potentially leading to abnormal walking patterns, reduced walking speed, and spatiotemporal asymmetries. Therefore, improving balance and walking is a fundamental goal in stroke rehabilitation and holds priority for many patients and their families.

Robot-assisted gait training (RAGT) is an emerging and promising technological approach in stroke rehabilitation. RAGT provides safe, high-intensity, and task-oriented walking training with ample repetitions. Repetitive tasks can enhance neuroplasticity and motor learning, resulting in improved balance and walking speed.

Robotic systems come in two types: end-effector and exoskeleton. The Lokomat® FreeD (Hocoma AG, Switzerland) is an exoskeleton-type robot. Unlike the conventional Lokomat, the FreeD module allows pelvic translation to the right and left, along with rotation. These coordinated pelvic movements are mechanically facilitated by the device during walking. It is known that these movements are crucial for human walking and balance, and with the FreeD module, these pelvic movements have become part of robot-assisted gait training.

In a systematic review comparing Lokomat with conventional physiotherapy, it was reported that Lokomat is equally effective in terms of balance. Another review found that patients undergoing robot-assisted gait training showed better improvement in balance compared to those not receiving this treatment. The literature supports Lokomat's positive effects on both balance and walking.

In this research, virtual reality applications on Lokomat® will be integrated as part of the exercises in the Lokomat group and virtual reality-based balance training using the Balance Trainer will be employed for the Balance-Trainer group.

Patients will be allocated to the Lokomat and Balance-Trainer groups based on the treatment they receive. Both systems are actively used in the hospital, which research conduct, for the purpose of actively treating patients who meet the research criteria for improving balance and walking in stroke survivors. Participants will engage in exercises with Lokomat® or Balance Trainer for three weeks, five sessions per week, each session lasting 30 minutes, totaling 15 sessions, in addition to their current rehabilitation program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 1, 2025
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Having the ICD-10 diagnosis code G.81 Hemiplegia

2. At least 3 weeks having passed since the diagnosis (Subacute and cronic periods)

3. Being 18 years of age or older

4. Having a Berg Balance Score between 21-40 (indicating an acceptable balance)

5. Being able to walk with or without support (FAC score of 2 or higher)

Exclusion Criteria:

1. Having a known additional neurological or orthopedic problem that could affect balance

2. Inability to adapt to virtual reality applications in Lokomat and Balance Trainer

3. Diagnosis being more than 2 years old

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Lokomat
Robot Assisted Gait Training
• Thera Trainer Balo
Virtual Reality Based Balance Training Device

Other:
• Person-Specific Rehabilitation Program
Person-Specific Rehabilitation Program

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	In the research, patient satisfaction was assessed using a scale ranging from 1 to 10. A higher score indicates better patient satisfaction. A score of 1 signifies complete dissatisfaction, while a score of 10 represents the highest level of satisfaction.	After last treatment seasion
Primary	Berg Balance Scale	This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.	Baseline and After last treatment seasion
Primary	Spatiotemporal Gait Analysis	In our research, spatiotemporal gait analysis will be conducted using the CMill VR+ device. As a result of gait analysis, parameters such as step lengths, swing, stance and double support phases, cadence, and levels of weight shifting to each side during walking will be recorded.	Baseline and After last treatment seasion
Secondary	Functional Independence Measure	The Functional Independence Measure is a valid and reliable scale for assessing stroke patients, comprising 18 items that evaluate the patient both physically and cognitively. These items are primarily grouped under the headings of Self-Care, Sphincter Control, Transfer, Locomotion, Communication, and Social Cognition.	Baseline and After last treatment seasion
Secondary	Functional Ambulation Category	It assesses the amount of physical support needed during walking, scoring from 0 to 5, with observations made through the assessment. The scoring is based on the amount of support the patient requires, ranging from 0 - indicating inability to ambulate independently and requiring maximum support, to 5 - defining a patient who can walk independently on all surfaces.	Baseline and After last treatment seasion