ROOD's Sensory Motor Training in Sub-acute Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Rood's Group; Other: Conventional Physical Therapy Group

• Registration Number: NCT04173481
• Lead Sponsor: Riphah International University

Brief Summary

The aim of this randomized controlled trial is to determine the effects of ROOD's sensory motor training along with Constraint Induced Movement Therapy (CIMT) in sub-acute stroke. Two randomized groups of patients with stroke were treated with conservative physical therapy and the experimental group was given ROOD's SMT and CIMT in conjunction with conservative rehabilitation. Both, male and female patients meeting the inclusion criteria were included. Patients having other neurological disease, chronic disease, not compatible being participates in CIMT or with any surgical intervention were excluded.

Detailed Description

The study is aimed at determining the effects of ROOD's sensory motor training along with constraint induced movement therapy in sub-acute stroke and is being conducted in National Institute of Rehabilitation Medicine Islamabad and Pakistan Railway General Hospital, Rawalpindi (Feb 2019-July 2019). Sample size of the study is 36 patients, 36 were included in the study on the basis of inclusion criteria, 18 for each group. Patients were allocated randomly and equally in each group. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ROOD's sensory motor training and CIMT training. Patients were examined at 1st visit before administration of any treatment and at 6th week which was also the last one (after completing 6 weeks sessions at alternate days). Baseline evaluation for demographics and assessment was taken. Fugyl-meyer assessment scale(FMA) and Wolf motor function test(WMFT) as measuring tools were used for first and 6th week assessment. 29 patients completed the study while 4 patient from control group and 3 patients from experiment group were lost to follow up and were considered drop outs.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Submitted: 2019-11-23
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Right & Left hemiplegia
• Ischemic & Hemorrhagic stroke
• Compatible with being participate in CIMT i.e. 10ºwrist extension,10ºany two fingers extension,10ºthumb abduction
• Duration of stroke between 6 weeks to 6 months

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Exclusion Criteria

• Not compatible with being participate in CIMT
• Any other neurological disease e.g. Parkinson's disease, brain tumors
• Chronic disease e.g. Ischemic Heart Disease, tumors, Diabetes Mellitus
• Behaviors issues, not willing to participate
• Surgical intervention that hinders treatment and assessment
• Not well oriented to follow designed motor task

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rood's Group	Rood's Group	Rood's sensory motor training along with CIMT
Conventional Physical Therapy Group	Conventional Physical Therapy Group	Conventional Physical Therapy including Proprioceptive Neuromuscular Facilitation technique.

Primary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	6 weeks	Changes from the baseline, Wolf motor function test is a test of motor ability that is use to evaluate the speed and coordination.; Total of 17 tasks performed by the patient.; Scoring: The items are rated on a 6-point scale as 0-6.
Fugyl-meyer motor assessment scale	6 weeks	Changes from the baseline, Fugyl-meyer assessment scale is use to assess voluntary movements, reflex activity, grasping and coordination of affected limb in stroke. FMA upper extremity portion contain 33 tasks with a scale 0 to 2 with maximum scoring of 66.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Islamabad, Pakistan