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StrokeNCT04807426

Multisensory Stimulation Exercises And Task Oriented Exercises On Upper Limb Function In Post Stroke Patients.

A study testing Multi Sensory stimulation exercises, Task Oriented Exercises and Task-oriented exercises and Multisensory stimulation Exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Multi Sensory stimulation exercises, Task Oriented Exercises and Task-oriented exercises and Multisensory stimulation Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
15 Aug 2020to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Combine Effects Of Multisensory Stimulation Exercises And Task Oriented Exercises On Upper Limb Function In Post Stroke Patients.

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.

Read more

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.

Read the detailed description

Stroke is defined as a neurological dysfunction due to sudden or acute injury to the central nervous system due to vascular causes, which includes cerebral infarction, intracranial hemorrhage and subarachnoid hemorrhage.Stroke is categorized as ischemic stroke (85%) and hemorrhage stroke (20%). Hemorrhagic stroke is further classified as interacerebral hemorrhage (15%) and subarachnoid hemorrhage (5%). Transient Ischemic attack (TIA) is a temporary blockage of blood flow to the brain and its symptoms resolves within 24 hours of the injury. Stroke is currently the second leading cause of death worldwide and is one of the leading causes of long-term disability in the United States. Almost 15 million stroke cases occur each year worldwide, resulting in 5 million deaths and leaving about 5 million stroke survivors with unchangeable abnormality and dependency.According to world health organization (WHO) in 2002 approximately 5.5 million people died due to stroke and 20% of these deaths occurred in south Asia .In Pakistan stroke cases reported are estimated to be 3,50,000 annually.Stroke survivors experience damaged upper limb function which also affects their activites of daily living. A large number of them is left with impaired upper extremity function, even after completion of conventional rehabilitation programmes.Only 5-20 % of patients regain Upper extremity functional status.Along with motor impairments somatosensory impairments are also assosoiated with severity of stroke but is overlooked most of the times. Sensory impairment decreases the ability to discriminate textures, weights ,shapes and sizes.Proprioception and stereognosis were found to be more impaired than tatile sensation ,7-53 % had impaired tactile sensations ,31-89% impaied sterognosis and 34-64 % impaired proprioception.Mostly, the focus is on motor recovery in paretic limb but the studies showed that improvement in sensory functions also leads to motor recovery. By only focusing on motor performance without sensory dysfunction assessment, maximum outcomes cannot be achieved.Not only Sensory dysfunction but Cognitive issues after stroke such as ,decreased perception and attention ,memory deficits ,difficulty in problem solving tend to be disregarded which eventually effects patient performance of daily activities.Multisensory stimulation exercises also known as neurocognitive therapeutic exercises, cognitive exercise therapy or cognitive sensory motor training was proposed by Carlo Perfetti of Italy .The Hallmark of this training is that it focuses on sensory retraining along with emphasis on joint position perception. It considers recovery as a learning process, the movement as a means to know and the body as a surface receptor for information.Laia Salles et.al conducted a randomized controlled pilot study to compare the effectiveness of the cognitive exercise therapy with conventional treatment protocol on upper limb in sub-acute stroke patients. The result showed favourable clinical progression regarding upper extremity functional gain.Sunghee Lee et.al did a study on effect of the cognitive exercise therapy on chronic stroke patients upper limb function, activities of daily living and quality of life .They compared it with Task oriented exercise group. There was significant difference between two groups and application of cognitive exercise therapy was found more effective for functional recovery in stroke patients.A study compared the effectiveness of cognitive sensory motor training therapy with conventional therapy on recovery of arm function in acute stroke patients. There were no significant differences found between two groups in acute stroke patients. The studies based on Multisensory stimulation exercises of perfetti focused on evaluating motor function of upper limb ,activities of daily living and quality of life but cognitive elements such as attention and memory also activated in discriminatory tasks and were not evaluated. The past records shows that in randomized controlled trials Multi sensory stimulation therapy is used alone for the experimental group .Combination of two protocols has not been analyzed yet .So, the aim of the study is to observe and determine the combine effect of Task Oriented Exercises and Multisensory stimulation exercises on upper limb function , Activities of daily living and Cognition .It is expected that the combination of these two approaches will give more significant results in improving sub-acute and chronic stroke patients condition.

Conditions
Stroke
Being tested
Multi Sensory stimulation exercises, Task Oriented Exercises, Task-oriented exercises and Multisensory stimulation Exercises
Keywords
stroke, Multisensory stimulation exercises, Task oriented exercises
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi Sensory stimulation exercisesOther

    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.

  • Task Oriented ExercisesOther

    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 ExercisesOther

    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.

Study groups in NCT04807426
Study groupRoleWhat they receive
Multi Sensory stimulation exercisesActive comparatoronly Multisensory stimulation Exercises
Receives: Other: Multi Sensory stimulation exercises
Task Oriented ExercisesExperimentalTask-oriented exercises without Multisensory stimulation Exercises
Receives: Other: Task Oriented Exercises
Task oriented exercises and Multisensory stimulation exercises.ExperimentalTask-oriented exercises with Multisensory stimulation Exercises
Receives: Other: Task-oriented exercises and Multisensory stimulation Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2021
  2. Study start15 Aug 2020
  3. Primary completion15 Nov 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04807426
Sponsor's protocol ID
REC/00657 Ayesha Rabbani
Status last verified
Mar 2021
First submitted
21 Dec 2020
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23652265
  • 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.

    PubMed 19211488
  • 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.

    PubMed 29791947
  • 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.

    PubMed 21487117
  • Khealani BA, Hameed B, Mapari UU. Stroke in Pakistan. J Pak Med Assoc. 2008 Jul;58(7):400-3.

    PubMed 18988415
  • 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.

    PubMed 8202977
  • 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.

    PubMed 8053790
  • 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.

    PubMed 18678576
  • 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.

    PubMed 30508935
  • 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.

    PubMed 16967344
  • 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.

    PubMed 28533607

Questions about this trial

What is this clinical trial studying?

A study testing Multi Sensory stimulation exercises, Task Oriented Exercises and Task-oriented exercises and Multisensory stimulation Exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugal Meyer assessment scale (time frame: 4weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04807426, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.

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