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

NCT07080099 | Completed DMC

• 1 other identifier: REC/RCR&AHS/24/0236
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; bimanual intensive training; sensory training

Outcome Measures

Primary Outcomes (3)

• FUGAL MEYER ASSESSMENT (FMA)

  The FMA assessment contained 33 items (divided into nine domains) regarding different movements, reflexes, and coordination. The assessment includes functional classes of upper extremity reflex activities, flexor synergy motion, extensor synergy motion, activities that were accompanied by synergy motion, disengaging movement, normal reflex action, and carpal joint stability.

  8 weeks

• NOTTINGHAM SENSORY ASSESSMENT

  The Nottingham Sensory Assessment is a standardized scale for assessing sensory impairment in stroke patients.

  8 weeks

• FUNCTIONAL INDEPENDENCE MEASURE (FIM)

  The Functional Independence Measure (FIM) is an instrument that was developed as a measure of a disability of populations. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.

  8 weeks

Study Arms (2)

Bimanual intensive with passive sensory training

EXPERIMENTAL

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.

Other: BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING

Bimanual intensive with active sensory training

EXPERIMENTAL

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.

Other: BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING

Interventions

BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING 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 passive sensory training

BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING 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.

Bimanual intensive with active sensory training

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Muhammad kashif

Lahore, Punjab Province, 54600, Pakistan

Location

Related Publications (14)

• 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.

  PMID: 22561098 BACKGROUND

• 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.

  PMID: 29933424 BACKGROUND

• 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.

  PMID: 34886287 BACKGROUND

• 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.

  PMID: 33052128 BACKGROUND

• 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.

  PMID: 33536067 BACKGROUND

• 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.

  PMID: 36550934 BACKGROUND

• 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.

  PMID: 36056243 BACKGROUND

• 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.

  PMID: 34311607 BACKGROUND

• 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.

  PMID: 34563008 BACKGROUND

• 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.

  PMID: 36419520 BACKGROUND

• 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.

  PMID: 34957959 BACKGROUND

• 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.

  PMID: 32004440 BACKGROUND

• 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.

  PMID: 32837228 BACKGROUND

• 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.

  PMID: 8784113 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• muhammad kashif, PHD

  Riphah International University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: February 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)