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ROOD's Sensory Motor Training in Sub-acute Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Rood's Group
Conventional Physical Therapy Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Proprioceptive Neuromuscular Facility, Hemiplegia, Neurorehabilitation, Neural Plasticity

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rood's Group

Conventional Physical Therapy Group

Arm Description

Rood's sensory motor training along with CIMT

Conventional Physical Therapy including Proprioceptive Neuromuscular Facilitation technique.

Outcomes

Primary Outcome Measures

Wolf Motor Function Test
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2019
Last Updated
November 23, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04173481
Brief Title
ROOD's Sensory Motor Training in Sub-acute Stroke
Official Title
Effects of ROOD's Sensory Motor Training Along With Constraint Induced Movement Therapy in Sub-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Proprioceptive Neuromuscular Facility, Hemiplegia, Neurorehabilitation, Neural Plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rood's Group
Arm Type
Experimental
Arm Description
Rood's sensory motor training along with CIMT
Arm Title
Conventional Physical Therapy Group
Arm Type
Active Comparator
Arm Description
Conventional Physical Therapy including Proprioceptive Neuromuscular Facilitation technique.
Intervention Type
Other
Intervention Name(s)
Rood's Group
Intervention Description
ROOD'S sensory motor training Brushing & strokings 3-5 strokings after 30sec, joint compressions and slow stretch 10 rep of 3 sets on alternative days for consecutive 6 weeks CIMT training Writing, combing hairs and using spoon activity 1 hour training concentrated on affected limb along with restraint of non affected limb by cotton sling under supervision of therapist and 5 hours training in home plan 3 times a week on alternative days for consecutive 6 weeks along with conventional physical therapy.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy Group
Intervention Description
Conventional training Proprioceptive neuromuscular facilitations (PNF) Combination of Isotonics technique 10 rep 3 sets 10 sec hold on alternative days for consecutive 6 weeks Stretching's 10 rep 3 sets on alternative days for consecutive 6 weeks Joint approximation 10 rep of 3 sets on alternative days for 6 weeks
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
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.
Time Frame
6 weeks
Title
Fugyl-meyer motor assessment scale
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Arif Hussain, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
440000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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ROOD's Sensory Motor Training in Sub-acute Stroke

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