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

NCT06459336 | Recruiting

• 1 other identifier: REC/RCR & AHS/23/0279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; upper extremity function

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intensive constraint-induced movement therapy

EXPERIMENTAL

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

Other: Intensive constraint-induced movement therapy

Distributed constraint-induced movement therapy

EXPERIMENTAL

Distributed participants will total of 36 hours treatment for 8 weeks

Other: Distributed constraint-induced movement therapy

Interventions

Intensive constraint-induced movement therapy OTHER

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

Intensive constraint-induced movement therapy

Distributed constraint-induced movement therapy OTHER

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

Distributed constraint-induced movement therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Hameed Latif Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 36987387 BACKGROUND

• 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.

  PMID: 37855247 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wajiha Shahid, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)