Clinical trial NCT06686303: Effects of Combined Segmental Vibrator and Neuromuscular Electrical Stimulation in Subacute Stroke
Official title: Combined Effects of Segmental Vibrator With Neuromuscular Electrical Stimulation for Flexor and Extensor Muscle Groups on Upper Limb Function in Sub Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is leading cause of death and disability worldwide, resulting in significant functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb. There is a need for more effective interventions targeting upper limb sensory motor impairments. The aim of this study is to study combined effect of segmental vibrator and neuromuscular electrical stimulation for flexor and extensor muscle groups on upper limb function in sub-acute stroke.

Detailed description: This study will be a randomized clinical trial and will be conducted in physiotherapy department of Allama Iqbal Memorial Teaching Hospital Sialkot, National Bone and Joint Hospital and Bashir Hospital Sialkot. Forty stroke patients will be recruited through non-probability convenience sampling technique and will be randomly divided in two equal groups Group A and group B through lottery method. Group A will receive high frequency segmental vibration on flexor and extensor muscle groups while group B will receive neuromuscular electrical stimulation along with high frequency segmental vibration(100Hz) on flexor and extensor muscle groups Data will be collected from patients of sub-acute stroke by using screening tool MoCA(for cognition) and assessment tools Fugl-Meyer Assessment Scale(for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity) , Barthel Index(for ADLs), Maximal Hand Grip Strength(for manual dexterity), Maximal Pinch Grip(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). An informed consent will be taken. Outcome measures will be assessed at baseline, at 4th week and at 8th week. Follow up will be performed at 12th week. Data analysis will be done by SPSS version 28.0.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders
* Aged between 45 and 65 years old
* First ever ischemic stroke experienced more than 3 months before the enrollment
* Spasticity of spastic agonist muscles ranging from 0-2 on the MAS

Exclusion Criteria:

* Patients with bilateral brain lesions
* Ischemic involvement of cerebellum or basal ganglia
* Psychiatric disease and cognitive impairment
* Previous history of other neurological diseases,rheumatic and orthopaedic conditions
* Patients under anti-spastic therapy or other clinical trials
* Metal implants e.g. cardiac pacemakers

Primary outcomes:
measure: MoCA(Montreal Cognitive Assessment)
timeFrame: Baseline and 8 weeks
measure: Fugl-Meyer Assessment
timeFrame: Baseline and 8 weeks
measure: Wolf Motor Functional Test
timeFrame: Baseline and 8 weeks
measure: Barthel Index
timeFrame: Baseline and 8 weeks
measure: Modified Ashworth Scale
timeFrame: Baseline and 8 weeks
measure: Maximal Hand and Pinch Grip Strength
timeFrame: Baseline and 8 weeks
measure: Nottingham Sensory Assessment
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: National Bone and Joint Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: