Effects of Bimanual Intensive Therapy With Sensory Training in Post Stroke Patients

NCT ID: NCT07080099

Last Updated: 2025-07-23

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-25

Study Completion Date

2024-09-30

Brief Summary

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Stroke is the major serious health burden and the leading cause of serious long term disability around the world. One of the most cumbersome deficits after a stroke is impairment in the contralateral upper limb. Bimanual intensive therapy (BIT) is a specialized approach used in rehabilitation for individuals, typically children, who have hemiplegia or hemiparesis, which means weakness or paralysis on one side of the body A therapy strategy known as "sensory training" aims to improve sensory integration and processing in people who struggle with sensory processing issues. The aim of this study is to determine the combined effects of bimanual intensive therapy with sensory training in addition conventional therapy on motor functions, sensory function and functional independence stroke patients.

Detailed Description

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This randomized clinical trial, will be conducted at jinnah hospital Lahore. For this study, the estimated sample size will be 38. The participants will be randomly allocated using online randomization tool into two groups; group A will receive the bimanual intensive training with passive sensory training for 45 minutes. Group B will receive bimanual intensive training with active sensory training for 45 minutes. Each participants will receive treatment for three days on alternative days for 8 weeks.

Fugal Meyer assessment will be used to asses' motor function. Nottingham Sensory assessment will be used to asses' sensory functions and Functional independence measure for activities of daily living. The data will be entered and analyzed using SPSS 26. Statistical significance will be set at p=0.05. Normality of data will be assessed through kolmogrove-smirnov test and shapirno-wilk test. Assessment will be carried out at bassline, 4th week and 8th week follow-up. For between group analyses of parametric data independent T test will be used, while Man Whitney test will be used for non-parametric data. For within groups comparison repeated measure Annona will be used, for non-parametric, Freidman Annona will be applied

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the study would be single blinded as the assessor of the study would be kept blind of the treatment groups to which patients will be allocated.

Study Groups

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Bimanual intensive with passive sensory training

Group A will receive bimanual intensive therapy with sensory training of 45 minutes with short resting intervals. Treatment will be given 3 times per week for 8 weeks.

Group Type EXPERIMENTAL

BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING

Intervention Type OTHER

Bimanual intensive therapy Bimanual coordination training ,Functional training of the hands ,Trask oriented training, Bilateral arm training,

Passive sensory training:

Electrical stimulation.

Bimanual intensive with active sensory training

Group B will receive bimanual intensive therapy with active sensory training of 45 minutes with short resting interval given to the patient. The treatment will be given 3 times per week for 8 weeks.

Group Type EXPERIMENTAL

BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING

Intervention Type OTHER

Bimanual intensive therapy:

* Bimanual coordination training ,Functional training of the hands
* Trask oriented training, bilateral arm reaching

Active sensory training:

sensory re education techniques ,touching different objects, massage, identifying different temperatures, and sensory locating.

Interventions

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BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING

Bimanual intensive therapy Bimanual coordination training ,Functional training of the hands ,Trask oriented training, Bilateral arm training,

Passive sensory training:

Electrical stimulation.

Intervention Type OTHER

BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING

Bimanual intensive therapy:

* Bimanual coordination training ,Functional training of the hands
* Trask oriented training, bilateral arm reaching

Active sensory training:

sensory re education techniques ,touching different objects, massage, identifying different temperatures, and sensory locating.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with age group 45 to 65
* Both genders
* Patients with stroke that was diagnosed clinically and/ or by computed tomography (CT) or magnetic resonance imaging
* Patient with stable vital signs and GCS score \>8-15
* Patients with mini mental state examination score\>24(30)

Exclusion Criteria

* Patients with severe cardiopulmonary complications
* Patients with history of epilepsy
* Patients with the presence of a pacemaker
* Patients with an history of an intracranial implant
* Patients with presence of a cranial defect
* Any other neurological conditions
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 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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muhammad kashif, PHD

Role: STUDY_CHAIR

Riphah International University

Locations

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Muhammad kashif

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Brunner IC, Skouen JS, Strand LI. Is modified constraint-induced movement therapy more effective than bimanual training in improving arm motor function in the subacute phase post stroke? A randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1078-86. doi: 10.1177/0269215512443138. Epub 2012 May 4.

Reference Type BACKGROUND
PMID: 22561098 (View on PubMed)

Ribeiro DKMN, Lenardt MH, Lourenco TM, Betiolli SE, Seima MD, Guimaraes CA. The use of the functional independence measure in elderly. Rev Gaucha Enferm. 2018 Jun 7;38(4):e66496. doi: 10.1590/1983-1447.2017.04.66496. English, Portuguese.

Reference Type BACKGROUND
PMID: 29933424 (View on PubMed)

Zamarro-Rodriguez BD, Gomez-Martinez M, Cuesta-Garcia C. Validation of Spanish Erasmus-Modified Nottingham Sensory Assessment Stereognosis Scale in Acquired Brain Damage. Int J Environ Res Public Health. 2021 Nov 29;18(23):12564. doi: 10.3390/ijerph182312564.

Reference Type BACKGROUND
PMID: 34886287 (View on PubMed)

Lin SH, Dionne TP. Interventions to Improve Movement and Functional Outcomes in Adult Stroke Rehabilitation: Review and Evidence Summary. J Particip Med. 2018 Jan 18;10(1):e3. doi: 10.2196/jopm.8929.

Reference Type BACKGROUND
PMID: 33052128 (View on PubMed)

Arya KN, Pandian S, Agarwal GG, Chaudhary N, Joshi AK. Effect of NEuroplasticity-Principles-based SEnsory-Rehabilitation (NEPSER) on sensori-motor recovery in stroke: study protocol for a randomized controlled trial. Neurol Res Pract. 2021 Feb 4;3(1):8. doi: 10.1186/s42466-021-00108-1.

Reference Type BACKGROUND
PMID: 33536067 (View on PubMed)

Huang JJ, Pei YC, Chen YY, Tseng SS, Hung JW. Bilateral Sensorimotor Cortical Communication Modulated by Multiple Hand Training in Stroke Participants: A Single Training Session Pilot Study. Bioengineering (Basel). 2022 Nov 24;9(12):727. doi: 10.3390/bioengineering9120727.

Reference Type BACKGROUND
PMID: 36550934 (View on PubMed)

Norwood MF, Lakhani A, Watling DP, Marsh CH, Zeeman H. Efficacy of Multimodal Sensory Therapy in Adult Acquired Brain Injury: A Systematic Review. Neuropsychol Rev. 2023 Dec;33(4):693-713. doi: 10.1007/s11065-022-09560-5. Epub 2022 Sep 2.

Reference Type BACKGROUND
PMID: 36056243 (View on PubMed)

Stoykov ME, Heidle C, Kang S, Lodesky L, Maccary LE, Madhavan S. Sensory-Based Priming for Upper Extremity Hemiparesis After Stroke: A Scoping Review. OTJR (Thorofare N J). 2022 Jan;42(1):65-78. doi: 10.1177/15394492211032606. Epub 2021 Jul 26.

Reference Type BACKGROUND
PMID: 34311607 (View on PubMed)

Kim KH, Jang SH. Effects of Cognitive Sensory Motor Training on Lower Extremity Muscle Strength and Balance in Post Stroke Patients: A Randomized Controlled Study. Clin Pract. 2021 Sep 14;11(3):640-649. doi: 10.3390/clinpract11030079.

Reference Type BACKGROUND
PMID: 34563008 (View on PubMed)

Arya KN, Pandian S, Joshi AK, Chaudhary N, Agarwal GG. Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. Ann Neurosci. 2022 Apr;29(2-3):104-115. doi: 10.1177/09727531221086732. Epub 2022 Apr 3.

Reference Type BACKGROUND
PMID: 36419520 (View on PubMed)

Sim TY, Kwon JS. Comparing the effectiveness of bimanual and unimanual mirror therapy in unilateral neglect after stroke: A pilot study. NeuroRehabilitation. 2022;50(1):133-141. doi: 10.3233/NRE-210233.

Reference Type BACKGROUND
PMID: 34957959 (View on PubMed)

Stinear CM, Lang CE, Zeiler S, Byblow WD. Advances and challenges in stroke rehabilitation. Lancet Neurol. 2020 Apr;19(4):348-360. doi: 10.1016/S1474-4422(19)30415-6. Epub 2020 Jan 28.

Reference Type BACKGROUND
PMID: 32004440 (View on PubMed)

Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.

Reference Type BACKGROUND
PMID: 32837228 (View on PubMed)

Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.

Reference Type BACKGROUND
PMID: 8784113 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/24/0236

Identifier Type: -

Identifier Source: org_study_id

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