Effect of Mental Imagery on Lower Limb Functions in Stroke

NCT ID: NCT05338918

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2023-02-05

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.

Detailed Description

Stroke causes inability to perform activities with affected limbs among which difficulty in walking and doing house chores are the most common dysfunctions. Stroke highly affects the productivity of people in family as well as in community. It also adds financial burden on families of patients. There are number of different restorative techniques and therapeutic approaches for the rehabilitation of stroke patients. For example, bobath approach, constrained induced movement therapy, mirror therapy, electrical stimulations, Circuit training, resistance training, Motor relearning program, proprioceptive neuromuscular facilitation, body weight supported treadmill for walking, Frenkel's exercises, repetitive task specific training, electromyography biofeedback and many others. All these approaches mainly focused on the repetition of tasks to perform a specific function, as the neuroplasticity requires repetition to occur. But there is a lack of interest, motivation and attention of stroke patients to perform similar tasks repeatedly. The lack of active participation directly or indirectly affects the neural stimulation and neural plasticity. One of the most emerging techniques in these days is Mental Imagery. Mental imagery(MI) is "a training method where imagination of movements, without actually moving, is used with the intention of improving motor performance" Currently Mental imagery has been used for neuro rehabilitation as it activates the same brain areas required for planning and execution of movements more or less in the same way require for actual performance of that movement. In this study the combination for Mental imagery and virtual reality is used for participation of patients in rehabilitation program which in turn increases the neural stimulation and causes neural plasticity to improve the motor performance. By increasing the functional activity, their ADL's can be improved to help them in becoming the active member of the society.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mental Imagery with Virtual Reality Group

Mental Imagery with Virtual Reality

Group Type: EXPERIMENTAL

Mental Imagery with Virtual Reality Training

Intervention Type: 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

Virtual Reality Alone Group

Virtual Reality Alone

Group Type: ACTIVE_COMPARATOR

Virtual Reality Training

Intervention Type: 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

Interventions

Mental Imagery with Virtual Reality Training

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

Intervention Type: OTHER

Virtual Reality Training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arshad Nawaz Malik, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

01261/Tasmiyah Asghar

Identifier Type: -

Identifier Source: org_study_id