Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| muhammad kashif, PHD | Riphah International University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhammad kashif | Lahore | Punjab Province | 54600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22561098 | Background | 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. | |
| 29933424 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING | Other | Bimanual intensive therapy:
Active sensory training: sensory re education techniques ,touching different objects, massage, identifying different temperatures, and sensory locating. |
|
| 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. |
| 34886287 | 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. |
| 33052128 | 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. |
| 33536067 | 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. |
| 36550934 | 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. |
| 36056243 | 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. |
| 34311607 | 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. |
| 34563008 | 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. |
| 36419520 | 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. |
| 34957959 | 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. |
| 32004440 | 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. |
| 32837228 | 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. |
| 8784113 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |