Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03168386
• Collaborator: (none)
• Enrollment: 196
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 85.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of motor rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Rehabilitation; Motor Function	Procedure: Intensive motor rehabilitation	N/A

Detailed Description

Intensive cognitive rehabilitation group

• physical and occupational therapy for 3 hours on every working day for 2 weeks

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Intenstive motor rehabilitationIntenstive motor rehabilitation
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
• Actual Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive motor rehabilitation group	Procedure: Intensive motor rehabilitation; Intensive motor rehabilitation during subacute stroke phase

Outcome Measures

Primary Outcome Measures

1. Upper limb score of Fugl-Meyer assessment [Change of upper limb score of Fugl-Meyer assessment after intensive motor rehabilitation for 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute first-ever stroke

• Upper limb score of Fugl-Meyer assessment at 7 days after onset : 25~84

Exclusion Criteria:

• Transient ischemic stroke

• Joint contracture of affected upper extremity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Yun-Hee Kim, MD,PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5.

• Responsible Party: Yun-Hee Kim, MD, PhD, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03168386
• Other Study ID Numbers: 2016-07-148
• First Posted: May 30, 2017
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 9, 2022