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Cognitive Sensorimotor Training With Whole Body Vibration for Cognitive Impairment

NCT ID: NCT06927492

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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A double-blinded randomized control trial will be conducted for ten months. The sample size was calculated through G-power and 50 participants will be recruited through the non-probability convenience sampling technique. Those who meet the inclusion criteria will be randomized into two groups (25 in the experimental group and 25 in the control group) through the online randomizer tool. The experimental group will receive cognitive sensorimotor training along with whole-body vibration. The control group will receive the cognitive sensorimotor training and Motor-cognitive dual-task training (mCdtt) simultaneously. Participants of each group will receive 60 minutes of training 3 times per week for 12 weeks. Outcome measures include the Montreal Cognitive Assessment (MoCA), the Stroop test will be used for the measurement of cognition and cognitive flexibility, the Mini bESTest for static and dynamic balance, and the Short physical performance battery for functional mobility. Assessment will be done at baseline, after the 6th week, 12th week, and at 16th week. Data analysis will be performed by using SPSS 26 software. Mixed ANOVA and repeated-measures ANOVA will be used for within-group analysis whereas between-group analysis will be performed by using one-way ANOVA.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A: Cognitive Sensorimotor training along with whole body vibration

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,

Group Type EXPERIMENTAL

Cognitive Sensorimotor training along with whole body vibration

Intervention Type 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.

B: Cognitive Sensorimotor training

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,

Group Type EXPERIMENTAL

Cognitive Sensorimotor training

Intervention Type 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,

Interventions

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Cognitive Sensorimotor training along with whole body vibration

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.

Intervention Type OTHER

Cognitive Sensorimotor training

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,

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aruba Saeed, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Society for the Rehabilitation of the Disabled (PSRD)

Lahore, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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REC/0260 Tooba Saher

Identifier Type: -

Identifier Source: org_study_id