Clinical trial NCT06927492: Cognitive Sensorimotor Training With Whole Body Vibration for Cognitive Impairment
Official title: Effects of Cognitive Sensorimotor Training With Whole Body Vibration on Cognition and Balance in Older Adults With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Keywords: Sensory motor training, WBV, functional mobility,short performance battery
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA):
timeFrame: 12 weeks
measure: Mini Balance Evaluation Systems Test (Mini-BESTest):
timeFrame: 12 weeks
measure: Short physical performance battery (SPPB)
timeFrame: 12 weeks
measure: The Stroop Color and Word Test (SCWT)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PhD
role: PRINCIPAL_INVESTIGATOR
References: