NCT04173481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 20, 2019

Last Update Submit

November 23, 2019

Conditions

Keywords

StrokeProprioceptive Neuromuscular FacilityHemiplegiaNeurorehabilitationNeural Plasticity

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 weeks

  • 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.

    6 weeks

Study Arms (2)

Rood's Group

EXPERIMENTAL

Rood's sensory motor training along with CIMT

Other: Rood's Group

Conventional Physical Therapy Group

ACTIVE COMPARATOR

Conventional Physical Therapy including Proprioceptive Neuromuscular Facilitation technique.

Other: Conventional Physical Therapy Group

Interventions

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.

Rood's Group

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

Conventional Physical Therapy Group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 440000, Pakistan

Location

Related Publications (14)

  • Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

    PMID: 23652265BACKGROUND
  • Redon J, Olsen MH, Cooper RS, Zurriaga O, Martinez-Beneito MA, Laurent S, Cifkova R, Coca A, Mancia G. Stroke mortality and trends from 1990 to 2006 in 39 countries from Europe and Central Asia: implications for control of high blood pressure. Eur Heart J. 2011 Jun;32(11):1424-31. doi: 10.1093/eurheartj/ehr045. Epub 2011 Apr 12.

    PMID: 21487117BACKGROUND
  • Umar M, Badshah M, Baig MS. Frequency of Dystonia Among Post Stroke Patients in Pakistan. Annals of PIMS ISSN. 2016;1815:2287.

    BACKGROUND
  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PMID: 21571152BACKGROUND
  • Doyle S, Bennett S, Fasoli SE, McKenna KT. Interventions for sensory impairment in the upper limb after stroke. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD006331. doi: 10.1002/14651858.CD006331.pub2.

    PMID: 20556766BACKGROUND
  • Lang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. J Hand Ther. 2013 Apr-Jun;26(2):104-14;quiz 115. doi: 10.1016/j.jht.2012.06.005. Epub 2012 Sep 10.

    PMID: 22975740BACKGROUND
  • Sawaki L, Butler AJ, Leng X, Wassenaar PA, Mohammad YM, Blanton S, Sathian K, Nichols-Larsen DS, Wolf SL, Good DC, Wittenberg GF. Constraint-induced movement therapy results in increased motor map area in subjects 3 to 9 months after stroke. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):505-13. doi: 10.1177/1545968308317531.

    PMID: 18780885BACKGROUND
  • Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.

    PMID: 25772900BACKGROUND
  • Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036.

    PMID: 21621674BACKGROUND
  • Schriner M, Thome J, Carrier M. Rehabilitation of the upper extremity after stroke: current practice as a guide for curriculum. The Open Journal of Occupational Therapy. 2014;2(1):6.

    BACKGROUND
  • Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.

    PMID: 24756870BACKGROUND
  • Nijland R, van Wegen E, Verbunt J, van Wijk R, van Kordelaar J, Kwakkel G. A comparison of two validated tests for upper limb function after stroke: The Wolf Motor Function Test and the Action Research Arm Test. J Rehabil Med. 2010 Jul;42(7):694-6. doi: 10.2340/16501977-0560.

    PMID: 20603702BACKGROUND
  • Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.

    PMID: 21164120BACKGROUND
  • Beekhuizen KS, Field-Fote EC. Sensory stimulation augments the effects of massed practice training in persons with tetraplegia. Arch Phys Med Rehabil. 2008 Apr;89(4):602-8. doi: 10.1016/j.apmr.2007.11.021.

    PMID: 18373988BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mir Arif Hussain, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 22, 2019

Study Start

February 1, 2019

Primary Completion

June 30, 2019

Study Completion

July 30, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations