Clinical trial NCT06459336: Comparative Effects of Intensive and Distributed CIMT on Upper Extremity Function in Stroke Patients
Official title: Comparative Effects of Intensive and Distributed Constraint-induced Movement Therapy on Upper Extremity Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
upper extremity function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity
timeFrame: 8th week
measure: Wolf motor function test
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hameed Latif Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajiha Shahid, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.