The Effects of Cerebellar Intermittent Theta Burst Stimulation on Gait, Balance, and Disease Anxiety In Stroke Patients

Not Applicable

Completed

• Conditions: Hemiplegia Following Ischemic Stroke

• Registration Number: NCT06696547
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Our study was designed to investigate the effect of cerebellar intermittent theta burst stimulation (iTBS) combined with conventional rehabilitation methods on balance, gait and disease anxiety in patients with ischemic stroke who have residual balance and gait disturbance, using clinical measurement parameters.

Detailed Description

Loss of balance and gait functions, which are neurological impairments related to stroke, are among the common functional losses depending on the affected brain region. Reduced independence in daily living activities can lead to increased anxiety during ambulation, risk of falling and fear of falling. Studies have shown that applying theta burst stimulation (TBS) to the cerebellum has long-term effects on the excitability of the cerebello-thalamo-cortical pathways and stimulates synaptic plasticity through various mechanisms. In the literature, there are studies examining the effects of cerebellar iTBS on balance and walking functions in stroke patients, but the number of studies are quite limited.

This study was planned as a prospective, randomized, sham-controlled clinical study. According to the statistical analysis 30 patients who were registered at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital between February 2022 and April 2023 and met the study criteria were included. The patients were divided into two groups: active (n=15) and sham (n=15). Each group received 30 sessions of either active or sham cerebellar iTBS (CRB-iTBS). Additionally, patients received therapeutic interventions from a physiotherapist, including range of motion exercises, stretching, neurophysiological exercises, balance-coordination training, active-assistive mobilization, and exercises for daily living.

The CRB-iTBS treatment targeted the cerebellum on the opposite side to the cerebral lesions, administered in a total of 30 sessions, twice a day with a 5-minute interval between sessions, over a period of 3 weeks. Each stimulation session consisted of 3-burst pulses at a frequency of 50 Hz, with a 10-second repetitive cycle of 2-second stimulations lasting a total of 190 seconds, delivering 600 pulses per session. Each day, a total of 1200 pulses were administered over two sessions, spaced 5 minutes apart. Patients in the sham CRB-iTBS group received the same protocol with a sham coil that visually resembled the active coil.

Clinical evaluations were conducted three times for each patient: Baseline (before treatment), 3rd week (at the and of treatment), and 6th week.

Study Timeline

• Study Start: 2022-02-28
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-16
• Last Update Submitted: 2024-11-16
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• First ischemic stroke,
• Duration between 2 months to 2 years post-stroke,
• Hemiparesis and residual gait and balance disorders related to the lesion in the MCA area (Berg Balance Scale score < 40),
• Lower extremity Brunnstrom value of at least 3 ,
• Mini Mental State Examination ≥ 24,
• Between 18-80 years old

Exclusion Criteria

• History of seizures,
• Severe general impairmet or concomittant disease,
• Using benzodiazepines, baclofen or antidepressants,
• Having a cardiac pacemaker, cochlear implant, metallic implants in the brain or skull,
• Pregnancy,
• Under 18 or over 80 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	This is a scale used to evaluate patients' balance during 14 different activities. These activities include: sitting to standig, standing unsupported, sitting unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing with feet together, reaching forward while standing, picking up an object from the floor, looking back over the shoulder on both the right and left sides, turning 360 degrees, placing a foot on a stool, standing in a toe-heel position, and standing on one foot. The total score after performing the test determines the predicted risk of falls. The minimum score on the test is 0, and the maximum score is 56. Scores are classified as follows: 0-20 indicates a high risk of falling, 21-40 indicates a moderate risk of falling, and 41-56 indicates a low risk of falling.
Gait Analysis- Step Length	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step length (cm).
Gait Analysis- Step Width	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step width (cm).
Gait Analysis- Walking Speed	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included walking speed (km/h).

Secondary Outcome Measures

Name	Time	Method
International Falls Efficacy Scale (FES-I)	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	Patients are evaluated for their level of concern about the risk of falling during 16 different activities. A score of 1 reflects no concern, while a score of 4 reflects a high level of concern. Total scores range from 16 to 64, with higher scores indicating greater anxiety about falling and lower self-confidence during activities.
Barthel Index for Activities of Daily Living (BI)	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	The Barthel Index (BI) was used to assess physical independence in daily activities on ten-item scale. These items are: feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfer (bed to chair and back), mobility (on level surfaces). Score of 0 indicating complete dependence and a score of 100 indicating complete independence.
Stroke Specific Quality of Life Scale (SS-QOL)	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	The Stroke-Specific Quality of Life Scale (SS-QOL) assesses the functionality and quality of life in stroke patients through 49 questions across 12 categories. These categories include: thinking, upper extremity functions, vision, work/productivity, social roles, self-care, personality, mood, mobility, language, family roles, and energy. Scoring is done on a scale from 1 to 5, with a total score ranging from 49 to 245. A score of 49 indicates very low quality of life, while a score of 245 indicates high quality of life.
Hospital Anxiety and Depression Scale (HADS)	Baseline (before treatment), 3rd week (at the end of treatment), 6th week	Hospital Anxiety and Depression Scale (HADS) consists of 14 questions, which are to be answered based on the patient's experience over the past few days while hospitalized. Seven of the questions assess depression, and seven assess anxiety levels. Separate scoring is done for anxiety and depression. The score may range between 0 and 21 per subscale. Higher scores indicate higher levels of anxiety and depression.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey