Effect of Mental Imagery on Lower Limb Functions in Stroke

NCT05338918 | Completed

• 1 other identifier: 01261/Tasmiyah Asghar
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of mental imagery and virtual reality training with virtual reality alone on lower limb functional status of stroke patients. The study will be a randomized controlled trial. After the initial evaluation randomization will be done on participants lying under the eligibility criteria. Randomized participants will be allocated to Control \& Experimental groups. Mental imagery (Audiotape recordings of some specific tasks for lower limb functions) with Virtual reality training given to experimental group while Virtual reality training alone to Control group. Task oriented training for balance \& gait as baseline treatment will be given to each group.

Conditions

Stroke

Keywords

Lower limb; Impairment; Mental practice; Virtual Reality training

Outcome Measures

Primary Outcomes (5)

• Fugl Meyer Assessment Scale - Lower Extremity

  This scale is recognized as a golden standard for assessment of motor function of stroke patients worldwide. It focuses on reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226 Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Balance: ranges from 0 to 14 points. Joint range of motion: ranges from 0 to 44 points. Joint pain: ranges from 0 to 44 points.

  6 weeks

• Berg Balance Scale

  changes from the baseline, Berg balance scale is used for assessment of balance and fall risk, Higher scores on the berg balance scale indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL \_\_/56

  6 weeks

• Timed Up and Go test

  changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: \<10 seconds = normal \<20 seconds = good mobility, can go out alone, mobile without a gait aid \<30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.

  6 weeks

• 10-meter walk test

  In this test, the participant walks through a 10-m walkway without any break. At the 4-m of walkway, time is recorded in order to obtain a rhythmic phase of walking speed. Then the time required over 3 trials was converted to the walking speed. The reliability of 10-m walk test is 0.83 and literature also shows the construct validity of 10-meter walk test.

  6 weeks

• Wisconsin Gait Scale

  This scale is used to assess gait cycle. It consists of 14 items, the higher the score, greater will be the disability. These scale focuses on the components of stance phase, guardedness of affected leg, toe off, swing phase and heel strike. The reliability of Wisconsin Gait Scale was 0.91 and 0.96 and Cronbach scores were 0.91 and 0.94 respectively. Minimum score is 13.35 \& maximum score is 42. The higher the score the more seriously affected the gait.

  6 weeks

Study Arms (2)

Mental Imagery with Virtual Reality Group

EXPERIMENTAL

Mental Imagery with Virtual Reality

Other: Mental Imagery with Virtual Reality Training

Virtual Reality Alone Group

ACTIVE COMPARATOR

Virtual Reality Alone

Other: Virtual Reality Training

Interventions

Mental Imagery with Virtual Reality Training OTHER

Mental Imagery TASK Practice with Virtual Reality Training: 30-40 minutes treatment sessions will be performed three times a week for six weeks, Part 1: 2-3 minutes of relaxation Part 2: Visual Imagery (external motor imagery training) for 5-8 minutes Part 3: Actual Task Practice for 10 minutes Part 4: Virtual Reality based training (including games for lower limb functions) for 10 minutes Part 5:Task Oriented training for 10 minutes Tasks for both (mental imagery + actual task practice) will be: Sit-stand task, Static stance (30 seconds), Indoor walk on a leveled surface, Walk indoor towards target, Forward / Side Stepping, Walking outdoors

Mental Imagery with Virtual Reality Group

Virtual Reality Training OTHER

Virtual Reality Training: 30-40 minutes treatment sessions will be performed three times a week for six weeks. Games will include River rush, 20000 water leaks, reflex ridge along with task oriented training. Tasks will be: Sit-stand task, Static stance (30 seconds), Indoor walk on a leveled surface, Walk indoor towards target, Forward / Side Stepping, Walking outdoors

Virtual Reality Alone Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with sub-acute/ chronic stroke (\>3 months)
• Modified Ashworth Ranking Scale 1-3
• Montreal Cognitive Assessment scoring \>24-30

You may not qualify if:

• Any active pathological condition
• Visual or hearing impairment
• Neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition
• Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative Joint Diseases etc.)
• Psychological issues

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46060, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arshad Nawaz Malik, 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 15, 2022
• First Posted: April 21, 2022
• Study Start: April 27, 2022
• Primary Completion: February 5, 2023
• Study Completion: February 5, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)