Comparative Effects of Intensive and Distributed CIMT on Upper Extremity Function in Stroke Patients

NCT ID: NCT06459336

Last Updated: 2024-06-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensive constraint-induced movement therapy

intensive protocol of CIMT of total 36 hours will be given in a week

Group Type EXPERIMENTAL

Intensive constraint-induced movement therapy

Intervention Type OTHER

Intensive protocol of CIMT will be given for 6hrs for 6 days to make total of 36 hours

Distributed constraint-induced movement therapy

Distributed participants will total of 36 hours treatment for 8 weeks

Group Type EXPERIMENTAL

Distributed constraint-induced movement therapy

Intervention Type OTHER

Distributed protocol of CIMT will be given for 2.25hrs two times a week for 8 weeks making total of 36 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensive constraint-induced movement therapy

Intensive protocol of CIMT will be given for 6hrs for 6 days to make total of 36 hours

Intervention Type OTHER

Distributed constraint-induced movement therapy

Distributed protocol of CIMT will be given for 2.25hrs two times a week for 8 weeks making total of 36 hours

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 40-70 years
* ischemic or hemorrhagic stroke
* Both genders eligible
* Gcs score ≥ 13
* Able to extend at least 10° at the fingers
* Able to extend at least 20° at the wrist
* Patients diagnosed with one side more affected(hemiplegia)
* Modified Ashworth scale score ≤2

Exclusion Criteria

* severe, chronic systemic illness
* Epilepsy
* History of fall past 6 months
* Injections of botulinum toxin type A or operations on the UE within 6 months
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wajiha Shahid, Phd

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hameed Latif Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Imran Amjad, Phd

Role: CONTACT

03324390125

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wajiha Shahid, Phd

Role: primary

+92-321-4885079

References

Explore related publications, articles, or registry entries linked to this study.

Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Effects of Intensive Versus Distributed Constraint-Induced Movement Therapy for Children With Unilateral Cerebral Palsy: A Quasi-Randomized Trial. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):109-118. doi: 10.1177/15459683231162330. Epub 2023 Mar 28.

Reference Type BACKGROUND
PMID: 36987387 (View on PubMed)

Kaneko T, Maeda M, Yokoyama H, Kai S, Obuchi K, Takase S, Horimoto T, Shimada R, Moriya T, Ohmae H, Amanai M, Okita Y, Takebayashi T. Therapeutic effect of adjuvant therapy added to constraint-induced movement therapy in patients with subacute to chronic stroke: a systematic review and meta-analysis. Disabil Rehabil. 2024 Sep;46(18):4098-4112. doi: 10.1080/09638288.2023.2269843. Epub 2023 Oct 19.

Reference Type BACKGROUND
PMID: 37855247 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR & AHS/23/0279

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.