Combined Effects of Transcranial Direct Current Stimulation on Postural Control in Elderly

Not Applicable

Recruiting

• Conditions: Postural; Defect

• Registration Number: NCT06757088
• Lead Sponsor: Riphah International University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-08
• Study Start: 2024-10-15
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg balance scale (BBS)	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)	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)	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)	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)	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.

Trial Locations

Locations (1)

Railway General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan