ROOD's Sensory Motor Training in Sub-acute Stroke

NCT ID: NCT04173481

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-07-30

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rood's Group

Rood's sensory motor training along with CIMT

Group Type EXPERIMENTAL

Rood's Group

Intervention Type 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

Conventional Physical Therapy including Proprioceptive Neuromuscular Facilitation technique.

Group Type ACTIVE_COMPARATOR

Conventional Physical Therapy Group

Intervention Type 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

Interventions

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Rood's Group

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

Conventional Physical Therapy 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mir Arif Hussain, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 23652265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21487117 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 21571152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20556766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22975740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18780885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25772900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21621674 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 24756870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20603702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21164120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18373988 (View on PubMed)

Other Identifiers

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RiphahIUAroosaTariq

Identifier Type: -

Identifier Source: org_study_id

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