Effect Of Triggered Functional Electrical Stimulation In Conjunction With Proprioceptive Neuromuscular Facilitation On Sitting Balance, Trunk Control And Functional Independence In Individuals With Stroke.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Sitting Balance (Sitting Balance Scale)
Study Overview
Brief Summary
Stroke is a debilitating neurological condition characterized by sensory, motor, autonomic, and/or bowel dysfunction caused by a lesion to the brain that leads to abnormal sitting balance, trunk control deficits and functional dependence. As most of the functional and other day to day activities performed are carried out in sitting position, sitting balance and trunk control is considered as a prerequisite for effective performance of day-to-day tasks and other activities.
Proprioceptive neuromuscular facilitation (PNF) and Functional electrical stimulation (FES) are two promising interventions that have shown to improve sitting balance, trunk control and functional independence in individuals with various neurological disorders, but their combined effectiveness has not been explored yet. Hence this research aims to find their effectiveness on sitting balance, trunk control and functional independence in individuals with stroke.
Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. One group will receive Triggered FES in conjunction with PNF along with conventional physiotherapy 5 times a week for 4 weeks. Whereas the second group will receive sham stimulation in conjunction with PNF along with conventional physiotherapy for the same duration.
The outcome measurements will be done by using the following scales: Sitting Balance Scale (SBS), Trunk Impairment Scale (TIS), Postural Assessment Scale for Stroke (PASS) and Functional Independence Measure (FIM) . Variations in outcome measurement scores: pre, post and 1 month follow up post completion will help us find out the effectiveness of triggered functional electrical stimulation in conjunction with proprioceptive neuromuscular facilitation on sitting balance, trunk control and functional independence and in individuals with stroke.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 50.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Hemiparesis with first stroke.
- •Duration ˃3 months.
- •Age: 50-70 years.
- •Those who can’t maintain unsupported sitting balance for five minutes.
- •Individuals with ≥ 4 stage of Brunnstorm motor recovery scale.
- •Mini‑Mental State Examination score ˃24.
Exclusion Criteria
- •Subjects with severe aphasia or cognitive impairment.
- •Subjects who were suffering from known case of brain tumor, head injury, infective conditions of brain, or from other neurological diseases.
- •Subjects with unilateral neglect.
- •Subjects with vestibular organ diseases.
- •Those who have electrical stimulation contraindication.
- •History of diagnosed musculoskeletal disorders of the trunk.
Outcomes
Primary Outcomes
Sitting Balance (Sitting Balance Scale)
Time Frame: Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention)
Trunk Control (Trunk Impairment Scale and Postural Assessment Scale for Stroke)
Time Frame: Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention)
Secondary Outcomes
- Functional Independence (Functional Independence Measure )(Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention))
Investigators
Harshita Jain
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences