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

NCT06757088 | Completed

• 1 other identifier: Summaiya Ishtiaq/01899
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural; Defect

Keywords

Posture; Old age; transcranial direct current

Outcome Measures

Primary Outcomes (5)

• Berg balance scale (BBS)

  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).

  3 weeks

• Timed Up and Go test (TUG)

  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.

  3 weeks

• Bestest Balance Evaluation-Systems Test (Bestest)

  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.

  3 weeks

• Twenty-five feet walk test (25FWT)

  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.

  3 weeks

• Six-minute walk test (6MWT)

  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.

  3 weeks

Study Arms (4)

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.

Device: M1 Stimulation Group

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

Device: Cerebellar Stimulation Group (CbSG)

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

Combination Product: M1 + Cerebellar Stimulation Group

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.

Device: Sham Stimulation Group

Interventions

M1 Stimulation Group DEVICE

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

M1 Stimulation Group (MSG)

Cerebellar Stimulation Group (CbSG) DEVICE

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

Cerebellar Stimulation Group (CbSG)

M1 + Cerebellar Stimulation Group COMBINATION_PRODUCT

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.

M1 + cerebellar stimulation group

Sham Stimulation Group DEVICE

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.

Sham Stimulation group (SSG)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46060, Pakistan

Location

Study Officials

• Arshad Nawaz Malik

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: January 3, 2025
• Study Start: October 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)