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

Stroke Clinical Trial

Official title:

Comparative Effects of Intensive and Distributed Constraint-induced Movement Therapy on Upper Extremity Function in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459336
• Other study ID #: REC/RCR & AHS/23/0279
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Intensive constraint-induced movement therapy
Intensive protocol of CIMT will be given for 6hrs for 6 days to make total of 36 hours
• 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

Locations

Country	Name	City	State
Pakistan	Hameed Latif Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. 2023 Oct 19:1-15. doi: 10.1080/09638288.2023.2269843. Online ahead of print. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment-Upper Extremity	It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).	8th week
Primary	Wolf motor function test	This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The original version of this test was developed by Dr. Steven L. Wolf, Emory University School of Medicine. The original version consisted of 21 items; the widely used version of the wolf motor function test consists of 17 items. it uses a Uses a 6-point ordinal scale i.e."0" means "does not attempt with the involved arm" to "5" means "arm does participate; movement appears to be normal."	8th week