NCT07642154

Brief Summary

Stroke is a neurological disorder causing 70-80 percent deaths in the low income and developing countries. Patients commonly present with common impairments associated with balance, proprioception, poor gait, speech impairment and posture which affect the activities of daily living along with increased risk and fear of fall. This negatively impacts patients' mobility, confidence and role in the society. Lower limb sensorimotor training targets the integration of sensory and motor systems enhancing tactile stimulation, balance and proprioception; whereas whole body vibration stimulates muscle spindles and mechanoreceptors via mechanical oscillations that may promote reflexive muscle contractions, improve muscle tone, and enhance postural responses. The aim of this study is to find the comparative effects of lower limb sensorimotor training and whole-body vibration therapy on balance, posture and fear of fall in post stroke patients. This study will be a randomized clinical trial. Non probability convenience sampling will be used to recruit 42 patients of either gender, aged 50-65 years, and diagnosed with stroke. This study will be carried out in Saira Memorial Hospital, Lahore. The participants will be randomly allocated to Group A and Group B through computerized table generator method. Each group will be given conventional physical therapy treatment as a baseline which includes range of motion exercises, balance and gait training. Group A will receive lower limb sensorimotor training, whereas group B will receive whole body vibration therapy. Each group will perform their respective exercises 45 minutes, three times a week for 8 weeks. The participants will be evaluated at the start and end of the exercise program through Berg Balance scale for dynamic balance, falls efficacy scale for risk of fall and Nottingham sensory assessment scale for sensory assessment. Data will be analyzed by SPSS version 26.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

StrokeSensorimotor trainingWhole body vibration therapyBerg balance scale

Outcome Measures

Primary Outcomes (1)

  • Postural Stability

    The Falls Efficacy Scale International is a measure of fear of falling or concerns about falling, developed as part of the Prevention of Falls Network Europe project between 2003 and 2006. It is a 16-item questionnaire, useful for researchers and clinicians interested in assessing fear of falling. The total score ranges from 16-64, with levels of concern classified as follows: Low Concern (16-19), indicating minimal concern about falling when engaging in daily activities; Moderate Concern (20-27), indicating a moderate level of concern and worry about falling during activities; and High Concern (28-64), reflecting a high level of fear and anxiety about falling during activities.(18)

    8 Weeks

Secondary Outcomes (1)

  • Dynamic Balance

    8 weeks

Study Arms (2)

Lower Limb Sensorimotor Training Exercises Group

EXPERIMENTAL

Sensorimotor training Participants of this group will be given task-specific training (reaching and walking activities), sensory stimulation training (tactile and proprioceptive activities), balance and postural control training (single leg stance and balance board training), and bilateral training (active recovery such as slow walking and light movements, constraint-induced movement therapy including mirror therapy), as well as practice of functional activities of daily living (bathing, combing, and eating with utensils). (19)

Behavioral: Sensorimotor Training

Whole Body Vibration Training Group

EXPERIMENTAL

Participants in this group will be given whole body vibration therapy including standing while vibrating (feet shoulder width apart and knees slightly bent on whole body vibrator), mini squats performed while vibrating, seated or assisted vibration (participants will sit on a chair or cushion placed on the platform and receives vibration therapy), upper body training while vibrating (participants will perform task-oriented upper limb exercises along with vibration therapy). The frequency of vibration for lower limb will be 11-z.(20)

Behavioral: Whole Body Vibration Training

Interventions

Component Frequency Intensity Time (minutes) Type Static Standing with vibration 3 times per week Low to moderate 5 minutes Participants stand with feet shoulder-width apart and knees slightly bent on whole body vibrator, receiving whole body vibration therapy. Mini Squats Performed while vibrating 3 times per week Low to moderate 5 minutes Participants perform min squats while receiving whole body vibration therapy Seated or Assisted Vibration 3 times per week Low to moderate 5 minutes Participants sit on a chair or cushion placed on the platform and receives vibration therapy. Upper Body Training while vibrating 3 times per week Low to moderate 5 minutes Participants will perform task-oriented upper limb exercises along with vibration therapy Vibration 3 times per Low to 5 minutes Participants will receive therapy along with functional tasks week moderate whole body vibration therapy while performing functional tasks like pegboard training

Whole Body Vibration Training Group

Component Frequency Intensity Time (minutes) Type Task- specific training 3 times per week Low to moderate 5 minutes Participants will perform reaching and walking activities. Sensory stimulation) 3 times/week Low to moderate 5 minutes Tactile and proprioceptive activities will be performed on participants. Balance/pos ture control 3 times/week Low to moderate 5 minutes Single leg stance and balance board training will be given to the patients. Bilateral training 3 times per week Low to moderate 5 minutes Active recovery (slow walking/light movement) exercises will be guided to the participants. Constraint- Induced Movement Therapy (CIMT) 3 times/week Low to Moderate 5 minutes Participants will involve in Mirror therapy. Functional activities (ADLs) 3 times per week Low to moderate 5 minutes Participants will perform functional activities like combing hair, pouring water, Eating with utensils, folding towels or clothes.

Lower Limb Sensorimotor Training Exercises Group

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female ranging from 50-65 years.
  • Definitive diagnosis of stroke .
  • Having sensory issues due to stroke in lower extremities.
  • Those who did not have a problem with walking due to other diseases other than stroke.
  • Having score less than 45 on berg balance scale.
  • Having no wounds, infections, and skin diseases in the feet, not taking medications such as nitroglycerin, dopamine, and dobutamine.
  • Having no history of mental illness, no suffering from osteoporosis, and not having neurological diseases. (7)

You may not qualify if:

  • Vestibular problems.
  • Severe cognitive decline and aphasia
  • Systemic diseases.
  • Cerebellar-related diseases.
  • Having acute and critical conditions during the intervention. (14)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saira Memorial Hospital

Lahore, Punjab Province, 42000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mohammad Hassan, Ms

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mohammad Hassan, MS

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

April 7, 2026

Primary Completion

June 7, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations