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临床试验/NCT06757088
NCT06757088已完成不适用

Effects of Combined Transcranial Direct Current Stimulation for Cerebral Cortex and Cerebellum on Postural Control in Elderly Population

Riphah International University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Berg balance scale (BBS)

研究概览

简要总结

The current study aims to determine the effects of combination stimulation (M1 Cortex+ Cerebellum) along with balance training (X-box with Kinect) on postural control in elderly population and to compare the combined stimulation (M1+CbS) with individual motor cortex, cerebellar or sham stimulation.

详细描述

The current study has been designed to investigate the potential effects of short term transcranial direct current stimulation on motor cortex and cerebellum both simultaneously and to document any additional benefits over each individual stimulations (M1 cortex stimulation, cerebellar stimulation or sham stimulation). Patients will be receiving the transcranial direct current stimulation combined with non-immersive virtual reality using Xbox 360 with Kinect in each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both genders
  • •Healthy elderly patients
  • •Age group of ≥ 60 years
  • •Fluent in reading and speaking Urdu language

排除标准

  • •Patients who have any congenital/Acquired walking or standing difficulty due to certain circumstances won't be included in the healthy adults group.
  • •Patients with Osteo-Arthritis (OA)
  • •Patients with cerebellar issues or issues such as vertigo with standing and walking etc.
  • •Individuals who had significant dysarthria or aphasia that might impair understanding of speech or verbal instruction
  • •Cognitive/communication impairment

研究组 & 干预措施

M1 Stimulation Group (MSG)

Active Comparator

For M1, the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

干预措施: M1 Stimulation Group (Device)

Cerebellar Stimulation Group (CbSG)

Other

For the CbSG, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle

干预措施: Cerebellar Stimulation Group (CbSG) (Device)

M1 + cerebellar stimulation group

Experimental

In M1, the anodal electrode will be placed over the M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region whereas simultaneously for the CbSG, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle

干预措施: M1 + Cerebellar Stimulation Group (Combination Product)

Sham Stimulation group (SSG)

Sham Comparator

In Sham stimulation, Electrodes will be placed according to M1 Stimulation i.e., the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

干预措施: Sham Stimulation Group (Device)

结局指标

主要结局

Berg balance scale (BBS)

时间窗: 3 weeks

Berg Balance Scale is considered gold standard for balance assessment. Patients are asked to complete 14 tasks, and each task is rated by an examiner on a 5-point scale ranging from 0 (cannot perform) to 4 (normal performance). Elements of the test are supposed to be representative of daily activities that require balance, including tasks such as sitting, standing, leaning over, and stepping. Some tasks are rated according to the quality of the performance of the task, whereas the time taken to complete the task is measured for other tasks. Overall scores can range from 0 (severely impaired balance) to 56 (excellent balance).

Timed Up and Go test (TUG)

时间窗: 3 weeks

The Timed Up and Go (TUG) test is a reliable, cost-effective, safe, and time-efficient way to evaluate overall functional mobility. The TUG has a high correlation with other proven tests that measure pure gait speed for longer lengths such as a 10-m walk.

Bestest Balance Evaluation-Systems Test (Bestest)

时间窗: 3 weeks

The Balance Evaluation Systems Test (BESTest) is a balance assessment that distinguishes 6 aspects of balance ability. Biomechanical constraints, limits of stability, anticipatory adjustments, postural responses, sensory orientation, and stability in gait. BESTest total score (ICC=0.98) and the BESTest sections (ICC between 0.85 and 0.96) have excellent intra-rater reliability. Inter-rater reliability for the total score was excellent (ICC=0.93) and, for the sections, it ranged between 0.71 and 0.94.

Twenty-five feet walk test (25FWT)

时间窗: 3 weeks

The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. Administration time will vary depending upon the ability of the patient. Total administration time should be approximately 1-5 minutes. The T25-FW has high inter-rater and test-retest reliability and shows evidence of good concurrent validity.

Six-minute walk test (6MWT)

时间窗: 3 weeks

The 6-minute walk test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. It is a simple, non-invasive, low-cost and reproducible exercise test used to evaluate endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes (6MWD) along a flat, straight course with a hard surface. The 6-min walk had good test-retest reliability (88 \< R \< 94), particularly when a practice trial preceded the test trial.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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