Cognitive Sensorimotor Training With Whole Body Vibration for Cognitive Impairment

NCT06927492 | Completed DMC

• 1 other identifier: REC/0260 Tooba Saher
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Aging is associated with cognitive decline, ranging from normal to mild cognitive impairment or dementia. This leads to physical and cognitive impairment, which are risk factors for loss of autonomy therefore physical and cognitive training are important for cognitively impaired older adults. Cognitive somatosensory exercise (CSE) is a special comprehensive rehabilitation program for retraining sensory-induced motor control, and whole-body vibration (WBV), which enhances neuromuscular function, cognition, and balance. This study aims to investigate the effects of combined cognitive sensory-motor training with whole-body vibration on cognition and balance in older adults with mild to moderate cognitive impairment.

Conditions

Cognitive Impairment

Keywords

Sensory motor training; WBV; Functional mobility; Short performance battery

Outcome Measures

Primary Outcomes (4)

• Montreal Cognitive Assessment (MoCA):

  The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale with 12 subtasks in the MoCA test including memory, visuospatial orientation, executive functioning, phonemic fluency, two-item abstract thinking task, attention, concentration, working memory, language, and orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment. Inter-rater Reliability (0.96) Cronbach's alpha (0.79).

  12 weeks

• Mini Balance Evaluation Systems Test (Mini-BESTest):

  The Mini-BESTest is a 14-item test that is a shortened version of the BESTest. It assesses important aspects of dynamic balance, including postural response to perturbation and gait stability. The Mini-BESTest has components of multiple individual balance assessments including items from the Berg Balance Scale, the Dynamic Gait Index, single-limb stance test, functional reach, Timed Up and Go, and modified Clinical Test of Sensory Interaction on Balance as well as a dual-task item and postural response items

  12 weeks

• Short physical performance battery (SPPB)

  The Short Physical Performance Battery (SPPB) allows the evaluation of limitations in the functioning of the lower limbs concerning the lower limb strength by five chair lifts, the balance by the tandem/semi-tandem position, and the walking speed by the 4 m walk. Each component is scored from 0 to 4 and summed to yield scores between 0 (poor) and 12 (best) performance (31). The scores are added together to obtain an overall performance score, with a maximum of 12. A high score is defined as a score above 10, a medium score between 9 and 7, and a low score below 6. (32). Test-retest reliability of the SPPB was high: 0.87 (CI95%: 0.77-0.96)

  12 weeks

• The Stroop Color and Word Test (SCWT)

  The Stroop test is a widely used executive function test to evaluate selective attention, speed of information processing, response inhibition and cognitive flexibility. In general, the Stroop effect occurs when individuals are presented with incongruent colour-word stimuli (e.g., the task requires to read the word "red" printed in blue ink or to name the colour of the ink instead of reading the word). Successful performance requires to inhibit an automatic behaviour (i.e., reading) in favour of a less practiced one (i.e., naming the colour of the ink). For all Stroop subtests, the completion times were the shortest for the individuals in the 18-29 age group with the highest education level and longest for the individuals in the 70-83 age group with the lowest education level. The test demonstrated acceptable internal consistency and high test-retest reliability.

  12 weeks

Study Arms (2)

A: Cognitive Sensorimotor training along with whole body vibration

EXPERIMENTAL

This group will receive sensorimotor training with cognitive dual-task training in addition to whole body vibration. The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks). The duration of one session for each group will be 60 minutes,

Other: Cognitive Sensorimotor training along with whole body vibration

B: Cognitive Sensorimotor training

EXPERIMENTAL

This group will receive sensorimotor training with cognitive dual task training simultaneously. The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks). The duration of one session for each group will be 60 minutes,

Other: Cognitive Sensorimotor training

Interventions

Cognitive Sensorimotor training OTHER

This group will receive sensorimotor training with cognitive dual task training simultaneously. The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks). The duration of one session for each group will be 60 minutes,

B: Cognitive Sensorimotor training

Cognitive Sensorimotor training along with whole body vibration OTHER

This group will receive sensorimotor training with cognitive dual-task training in addition to whole body vibration. The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks). The duration of one session for each group will be 60 minutes, The whole-body vibration will be administered using a vibration machine. This includes asking the patient to stand barefoot on the vibrator platform evenly distributing their body weight on both feet with knees bent at 20 degrees as flexing of knees is a common postural adaptation used to minimize transmission of vibration to the head. The patients will receive the whole body vibration at 30Hz consisting of three sessions per week with at least one day between sessions for 12 weeks. The time for each session will be 15 minutes (five bouts of 2 min) . There will be a rest of 1 minute between each bout of vibration therapy.

A: Cognitive Sensorimotor training along with whole body vibration

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants fulfilling given criteria will be included in this study
• Both male and female participants will be included
• The age limit for the participants will be 60 to 75
• Participants with mild to moderate cognitive impairment having a Montreal Cognitive Assessment (MoCA) score of 13-25 (out of 30)
• Participants with mild to moderate balance impairment having Mini BESTest cut-off score 13-28

You may not qualify if:

• Participants having given criteria will be excluded from this study
• Participants having major depressive and anxiety disorder
• Participants having significant visual and auditory impairment
• Participants having a prior history of neurological disease or brain injury, and psychiatric disorders
• Participants having cerebrovascular infarction
• Participants having a neurological condition (epilepsy, loss of consciousness leading to a fall (e.g. vertigo syndrome)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Society for the Rehabilitation of the Disabled (PSRD)

Lahore, 54660, Pakistan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Aruba Saeed, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 30, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)