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CompletedNCT06757088Updated Mar 11, 2025

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

An interventional study of M1 Stimulation Group and Cerebellar Stimulation Group (CbSG) in Postural; Defect, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postural; Defect

Keywords

  • Posture
  • Old age
  • transcranial direct current
03

In context

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    M1 Stimulation Group (MSG)

    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

  • Other
    Cerebellar Stimulation Group (CbSG)

    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)

  • Experimental
    M1 + 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

    Combination Product: M1 + Cerebellar Stimulation Group

  • Sham comparator
    Sham Stimulation group (SSG)

    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

  • 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.

  • DeviceCerebellar Stimulation Group (CbSG)

    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.

  • DeviceSham Stimulation Group

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 weeks

  2. 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.

    Time frame: 3 weeks

  3. 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.

    Time frame: 3 weeks

  4. 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.

    Time frame: 3 weeks

  5. 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.

    Time frame: 3 weeks

07

Study locations

1 site
  • Railway General Hospital
    Rawalpindi, Punjab 46060, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06757088
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jan 3, 2025
Start date
Oct 15, 2024
Primary completion
Feb 15, 2025
Completion
Feb 15, 2025
Last update
Mar 11, 2025

Study contacts

Arshad Nawaz Malik
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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