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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06757088
Enrollment
52
Registered
2025-01-03
Start date
2024-10-15
Completion date
2025-02-15
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural; Defect

Keywords

Posture, Old age, transcranial direct current

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.

Interventions

DEVICEM1 Stimulation Group

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

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

COMBINATION_PRODUCTM1 + Cerebellar Stimulation Group

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.

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.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Berg balance scale (BBS)3 weeksBerg 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 weeksThe 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 weeksThe 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 weeksThe 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 weeksThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026