The Effect of Cerebellar Intermittent Theta Burst Stimulation Combined With Conventional Rehabilitation Methods on Gait, Balance, and Disease Anxiety in Patients With Ischemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemiplegia Following Ischemic Stroke
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Berg Balance Scale (BBS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Miray Karamehmetoğlu
M.D., Principal Investigator
Ankara City Hospital Bilkent
Eligibility Criteria
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
Outcomes
Primary Outcomes
Berg Balance Scale (BBS)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- International Falls Efficacy Scale (FES-I)(Baseline (before treatment), 3rd week (at the end of treatment), 6th week)
- Barthel Index for Activities of Daily Living (BI)(Baseline (before treatment), 3rd week (at the end of treatment), 6th week)
- Stroke Specific Quality of Life Scale (SS-QOL)(Baseline (before treatment), 3rd week (at the end of treatment), 6th week)
- Hospital Anxiety and Depression Scale (HADS)(Baseline (before treatment), 3rd week (at the end of treatment), 6th week)