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NCT Number: NCT04173481

ROOD's Sensory Motor Training in Sub-acute Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Islamabad, 440000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rood's Group

Other

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.

Conventional Physical Therapy Group

Other

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 outcomes

  1. Wolf Motor Function Test

    Time frame: 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.

  2. Fugyl-meyer motor assessment scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of ROOD's Sensory Motor Training Along With Constraint Induced Movement Therapy in Sub-acute Stroke

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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