NCT04807426

Brief Summary

The objective of the study was to determine the effects of Multisensory stimulation exercises and Task-oriented exercises on upper limb function and to determine the effects of Multisensory stimulation exercises and Task-oriented exercises on Activities of daily living and cognition . Study Design was Randomized control trial. Sampling Technique was purposive sampling. Study Setting was Physiotherapy department of Railway General Hospital Rawalpindi and NIRM Islamabad. Inclusion criteria were patients with hemiplegia due to stroke, Both male \& female, Sub-acute and chronic stroke patients, First-ever stroke patient, Age between 40 -65, Modified Ashworth scale \<3. Exclusion criteria were Un bearable upper limb pain, Recent surgery, Visual impairment and Non cooperative Patients. Total sample size calculated, by using epi tool is 12. Assessment tools used were Fugal Meyer motor assessment scale, Wolf motor function test, Revised Nottingham sensory, Motor activity log and Montreal cognitive assessment. Individuals who met the inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups Experimental group 1 and Experimental group 2. The pre-intervention assessment was made for both groups. Then intervention was applied to both groups.All statistical analyses will be performed through SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2020

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

August 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

December 21, 2020

Last Update Submit

March 18, 2021

Conditions

Keywords

strokeMultisensory stimulation exercisesTask oriented exercises

Outcome Measures

Primary Outcomes (1)

  • Fugal Meyer assessment scale

    This test is used to measure changes from baseline to 4 weeks. Fugal Meyer assessment scale is used to evaluate paretic upper extremity voluntary movements, reflex activity, grasping and coordination .FMA- UE contains 33 tasks with a scale of 0 to 2 with total scoring of 66. Reliability of FMA is 0.95-1.0

    4weeks

Other Outcomes (4)

  • Wolf Motor Function Test

    4 weeks

  • Reversed Nottingum Sensory Assessment scale

    4 weeks

  • Motor Activity log

    4 weeks

  • +1 more other outcomes

Study Arms (3)

Multi Sensory stimulation exercises

ACTIVE COMPARATOR

only Multisensory stimulation Exercises

Other: Multi Sensory stimulation exercises

Task Oriented Exercises

EXPERIMENTAL

Task-oriented exercises without Multisensory stimulation Exercises

Other: Task Oriented Exercises

Task oriented exercises and Multisensory stimulation exercises.

EXPERIMENTAL

Task-oriented exercises with Multisensory stimulation Exercises

Other: Task-oriented exercises and Multisensory stimulation Exercises

Interventions

Multi Sensory stimulation exercises:Identification tasks will be given to a blindfolded patient. Which includes recognizing shapes, sizes , textures ,Identifying heights , hardness , weight discrimination .Difficulty will be added by increasing the objects to be identified. Joint angle perception training will be started with one joint perception and will advance to multiple joints position perception. Task Oriented Exercises: Patient will perform upper limb functional activities such as Reaching for objects, putting up and down an object, hand to mouth activity, combing hair, folding piece of cloth grasp and release activity, opening a jar, putting beads in jar and writing letters or draw something will be done. Complexity is added by increasing speed of task performance. Conservative Management:Passive stretching exercises for paretic upper extremity muscles .Stretchings will be applied for 30 sec with 30 sec rest, 10 repetitions for1 set.

Multi Sensory stimulation exercises

Task Oriented Exercises: Patient will perform upper limb functional activities such as Reaching for objects, putting up and down an object, hand to mouth activity, combing hair, folding piece of cloth grasp and release activity, opening a jar, putting beads in jar and writing letters or draw something will be done. Complexity will be added by increasing speed of task performance. Conservative Management:Passive stretching exercises for paretic upper extremity muscles . Stretchings will be applied for 30 sec with 30 sec rest, 10 repetitions for1 set.

Task Oriented Exercises

Multi Sensory stimulation exercises:Identification tasks will be given to a blindfolded patient. Which includes recognizing shapes, sizes , textures ,Identifying heights , hardness , weight discrimination .Difficulty will be added by increasing the objects to be identified. Joint angle perception training will be started with one joint perception and will advance to multiple joints position perception. Task Oriented Exercises: Patient will perform upper limb functional activities such as Reaching for objects, putting up and down an object, hand to mouth activity, combing hair, folding piece of cloth grasp and release activity, opening a jar, putting beads in jar and writing letters or draw something will be done. Complexity will be added by increasing speed of task performance. Conservative Management:Passive stretching exercises for paretic upper extremity muscles . Stretchings will be applied for 30 sec with 30 sec rest, 10 repetitions for1 set.

Task oriented exercises and Multisensory stimulation exercises.

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hemiplegia due to stroke
  • Sub-acute and chronic stroke patients
  • First-ever stroke patient
  • Modified Ashworth scale \<3

You may not qualify if:

  • Patient that is not well oriented to understand the command to follow the designed motor task
  • Un bearable upper limb pain
  • Patient with any type of surgical intervention which may hinder assessment and treatment.
  • Patients with any other neurological disease
  • Non cooperative Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (11)

  • 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
  • Appelros P, Stegmayr B, Terent A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009 Apr;40(4):1082-90. doi: 10.1161/STROKEAHA.108.540781. Epub 2009 Feb 10.

    PMID: 19211488BACKGROUND
  • Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.

    PMID: 29791947BACKGROUND
  • 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
  • Khealani BA, Hameed B, Mapari UU. Stroke in Pakistan. J Pak Med Assoc. 2008 Jul;58(7):400-3.

    PMID: 18988415BACKGROUND
  • Duncan PW, Goldstein LB, Horner RD, Landsman PB, Samsa GP, Matchar DB. Similar motor recovery of upper and lower extremities after stroke. Stroke. 1994 Jun;25(6):1181-8. doi: 10.1161/01.str.25.6.1181.

    PMID: 8202977BACKGROUND
  • Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Compensation in recovery of upper extremity function after stroke: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Aug;75(8):852-7. doi: 10.1016/0003-9993(94)90108-2.

    PMID: 8053790BACKGROUND
  • Connell LA, Lincoln NB, Radford KA. Somatosensory impairment after stroke: frequency of different deficits and their recovery. Clin Rehabil. 2008 Aug;22(8):758-67. doi: 10.1177/0269215508090674.

    PMID: 18678576BACKGROUND
  • Chen X, Liu F, Yan Z, Cheng S, Liu X, Li H, Li Z. Therapeutic effects of sensory input training on motor function rehabilitation after stroke. Medicine (Baltimore). 2018 Nov;97(48):e13387. doi: 10.1097/MD.0000000000013387.

    PMID: 30508935BACKGROUND
  • Barker-Collo S, Feigin V. The impact of neuropsychological deficits on functional stroke outcomes. Neuropsychol Rev. 2006 Jun;16(2):53-64. doi: 10.1007/s11065-006-9007-5. Epub 2006 Aug 9.

    PMID: 16967344BACKGROUND
  • Salles L, Martin-Casas P, Girones X, Dura MJ, Lafuente JV, Perfetti C. A neurocognitive approach for recovering upper extremity movement following subacute stroke: a randomized controlled pilot study. J Phys Ther Sci. 2017 Apr;29(4):665-672. doi: 10.1589/jpts.29.665. Epub 2017 Apr 20.

    PMID: 28533607BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dr Aruba Saeed, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

March 19, 2021

Study Start

August 15, 2020

Primary Completion

November 15, 2020

Study Completion

December 30, 2020

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations