Skip to main content
Clinical Trials/NCT06757088
NCT06757088
Completed
Not Applicable

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

Riphah International University1 site in 1 country52 target enrollmentOctober 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postural; Defect
Sponsor
Riphah International University
Enrollment
52
Locations
1
Primary Endpoint
Berg balance scale (BBS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2024
End Date
February 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Berg balance scale (BBS)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials