Designing and testing effect of multipurpose wrist and hand device on spasticity, motor function and quality of life in stroke subjects with wrist and hand dysfunction – an exploratory study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Modified Tardieu Scale
Study Overview
Brief Summary
• Ethical Clearance from university.
• Searching online database and discussion with experts for forming design of Frame, dynamic splint and electrical stimulator.
• Final design will be given to biomedical engineer and tentative device would be formed by 3 D designing
• Tentative model will be tested on healthy individuals and discuss with experts
• After final corrections from design of device trial for its effectiveness would be performed on stroke patients.
• Subjects assessed for inclusion criteria, information about device and aim of study will be given and informed consent will be taken
• Baseline assessment for outcome measure i.e. Fugl Meyer, Modified Tardieu scale and SF 36 will be taken
• Subjects will be divided into 2 groups i.e. Group A and Group B by Random sampling
• Group A - Conventional treatment
Group B – 45 minutes/ Day task specific training with device along with conventional treatment
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 40.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a.Patients with > 3 months post-stroke duration. b.Age group.
- •40 to 65 years c.Mini mental scale examination score- >24 d.Skin intact on hemi paretic arm e.Medically stable.
Exclusion Criteria
- •1.MAS ≥ 3 2.Visual Hemi Neglect 3.Other acute injuries to arms or hands 4.IM Botox injections in any UE muscle in the last 3 months 5.Patients with cardiac pacemaker 6.Stroke patients who are not cooperative 7.Stroke patients who have auditory &/or visual deficits.
- •Stroke patients who do not have proper medical History 9.Patients having another neurological deficit with stroke.
Outcomes
Primary Outcomes
Modified Tardieu Scale
Time Frame: Pre and post 4 weeks
Fugl Meyer wrist and hand subscale
Time Frame: Pre and post 4 weeks
QUEST (Quebec user evaluation satisfaction with assistive technology)
Time Frame: Pre and post 4 weeks
Secondary Outcomes
- SF-36(Pre and post 4 weeks)