Effectiveness of Arm Ability Training versus Task Oriented Training on upper limb function and quality of life for Sub Acute stroke subjects.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- 1. Graded Wolf Motor Function Test (gWMFT)
Study Overview
Brief Summary
This Study is a Single blinded randomized controlled trail to find the effectiveness of Arm Ability Training versus Task Oriented training on Upper limb function and Quality of life for sub-acute stroke subjects.
Data samples will be collected from out patient department of Jaya college of Paramedical sciences, college of Physiotherapy, Thiruninravur.
The baseline data regarding name, age, sex, stroke duration, the side of involvement, MMSE and Brunnstorm recovery stage was taken after informed consent for all subjects.
135 stroke subjects randomly allocated as Group A (Conventional Group): 45 subjects Group B (Arm Ability Training): 45 Subjects Group C (Task oriented Training): 45 Subjects.
The Anthropometric measurements includes BMI, and Triceps Skin fold Thickness.
The Primary outcomes were Graded Wolf Motor Function test (Motor Functioning), Modified Nine Hole Peg Test with Auto Timer (Manual Dexterity) and Stroke Specific quality of Life ( HRQoL).
The Post test scores were taken after the period of 3 weeks. The Pre and Post-test were compared. Statistical Analysis were done using Paired, Unpaired ‘t’ tests, Chi-square tests and ANOVA
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •i BMI 24 to 29.9 ii Had a first episode of unilateral MCA stroke iii Both Ischemic and Hemorrhagic stroke iv Endocrine disorders like Diabetes, Hypertension v Sub acute stroke more than 3 months vi Person with dominant Hand involvement vii Brunnstrom score between stages II and III for the upper extremity viii Mini Mental State Examination score greater than or equal to 24 and 21 for illiterate ix Able to sit independently for 30 minutes.
Exclusion Criteria
- •i Neurological disease (Parkinson’s disease, Alzhimer disease) ii Musculoskeletal problems (deformities, recent fracture, degenerative disorders) iii Any Systemic disease iv Pain (score 1 or at least 2 joints) v Aphasia vi Patients with severe somatosensory deficit vii Severe shoulder pain affecting therapy viii Any comorbid condition that could limit upper extremity function ix Visual or hearing impairment.
- •x Patients with repetitive stress injury xi Patients with Psychological problem.
Outcomes
Primary Outcomes
1. Graded Wolf Motor Function Test (gWMFT)
Time Frame: 2 years
2.Gross Manual Dexterity
Time Frame: 2 years
(Modified 9-hole peg board test with Auto-timer)
Time Frame: 2 years
3. Triceps Skin fold Thickness
Time Frame: 2 years
4.HRQoL: Stroke Specific quality of life questionnaire
Time Frame: 2 years
Secondary Outcomes
- HRQoL: Stroke Specific quality of life questionnaire
Investigators
Mythili D
The Tamil Nadu Dr MGR Medical University Guindy