StrokeBITNCT07080099
Effects of Bimanual Intensive Therapy With Sensory Training in Post Stroke Patients
A study testing BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING and BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING and BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 30 Sep 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bimanual Intensive Therapy With Sensory Training on Motor Function, Sensory Function and Functional Independence in Post Stroke Patients
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.
Read the detailed description
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
- Stroke
- Being tested
- BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING, BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING
- Keywords
- stroke, bimanual intensive training, sensory training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAININGOther
Bimanual intensive therapy Bimanual coordination training ,Functional training of the hands ,Trask oriented training, Bilateral arm training,
Passive sensory training:
Electrical stimulation.
BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAININGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
NOTTINGHAM SENSORY ASSESSMENT
The Nottingham Sensory Assessment is a standardized scale for assessing sensory impairment in stroke patients.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Feb 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- muhammad kashif, PHD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080099
- Sponsor's protocol ID
- REC/RCR&AHS/24/0236
- Acronym
- BIT
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22561098Ribeiro 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.
PubMed 29933424Zamarro-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.
PubMed 34886287Lin 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.
PubMed 33052128Arya 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.
PubMed 33536067Huang 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.
PubMed 36550934Norwood 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.
PubMed 36056243Stoykov 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.
PubMed 34311607Kim 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.
PubMed 34563008Arya 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.
PubMed 36419520Sim 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.
PubMed 34957959Stinear 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.
PubMed 32004440Murphy 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.
PubMed 32837228Taylor 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.
PubMed 8784113
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bimanual Intensive Therapy With Sensory Training on Motor Function, Sensory Function and Functional Independence in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT07080099
- Acronym / sponsor ID
- BIT / REC/RCR&AHS/24/0236
- Conditions
- Stroke
- Keywords
- stroke, bimanual intensive training, sensory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimanual intensive with passive sensory training | Experimental | Other: BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAININGGroup 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 | Other: BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAININGGroup 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAININGBimanual intensive therapy Bimanual coordination training ,Functional training of the hands ,Trask oriented training, Bilateral arm training, Passive sensory training: Electrical stimulation. | Other | Bimanual intensive with passive sensory training |
| BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAININGBimanual 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. | Other | Bimanual intensive with active sensory training |
Primary outcome
FUGAL MEYER ASSESSMENT (FMA)
Time frame: 8 weeks
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.
NOTTINGHAM SENSORY ASSESSMENT
Time frame: 8 weeks
The Nottingham Sensory Assessment is a standardized scale for assessing sensory impairment in stroke patients.
FUNCTIONAL INDEPENDENCE MEASURE (FIM)
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 22561098Brunner 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.
- Background: PubMed 29933424Ribeiro 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.
- Background: PubMed 34886287Zamarro-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.
- Background: PubMed 33052128Lin 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.
- Background: PubMed 33536067Arya 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.
- Background: PubMed 36550934Huang 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.
- Background: PubMed 36056243Norwood 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.
- Background: PubMed 34311607Stoykov 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.
- Background: PubMed 34563008Kim 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.
- Background: PubMed 36419520Arya 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.
- Background: PubMed 34957959Sim 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.
- Background: PubMed 32004440Stinear 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
muhammad kashif, PHD study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING and BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING 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 5 inclusion and 6 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 23 Jul 2025. 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 (FMA) (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT07080099, which also lists 14 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 23 Jul 2025.