Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.

October 26, 2023 updated by: Riphah International University
To determine effects of short-intensity modified constraint-induced movement therapy on hand function in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to determine the effects of a short-intensity modified CIMT (mCIMT) program on hand function in stroke patients. This study will be a randomized controlled trial comprising two groups, an experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which participants will be given conventional therapy alone. Patients will be assessed with the Wolf Motor Function Test, the Motor Activity Log, and the Ashworth Scale before and after treatment. The data will be analyzed by using SPSS for windows software version 25. Statistical significance will be set at p=0.05.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients having the First stroke either ischemic or hemorrhagic (3-24 months after stroke)
  • Patients having Mini-mental status examination score (MMSE) ≤23/30
  • Patients having Passive range of motion (PROM) includes at least 90 degrees shoulder flexion and abduction, 45degrees shoulder external rotation,- 30 degrees elbow extension, and 45 degrees forearm supination and pronation (from a neutral position). At least 10 degrees active wrist extension, 10 degrees abduction/thumb extension, and 10-degree extension at the level of the metacarpophalangeal and interphalangeal joints between the two toes among the II-III-IV-V fingers (these movements will be repeated starting from a resting position 3 times in 1 minute).

Exclusion Criteria:

  • Patients having Subarachnoid hemorrhage.
  • Patients having Motor activity log - the amount of use score ≥2.5
  • Patients having treatment of upper limb spasticity (e.g., botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
an experimental group receiving short-intensity modified CIMT and conventional therapy
Other: short-intensity modified CIMT and conventional therapy
an experimental group receiving short-intensity modified CIMT and conventional therapy
Active Comparator: control group
a control group receiving conventional therapy alone.
Other: conventional therapy alone
a control group receiving conventional therapy alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wolf motor function test (WMF)
Time Frame: 9 months

Wolf motor function test (WMF) is a new time-based method for evaluating upper extremity performance that provides insight into joint-specific and whole limb movements.

To investigates the effects of mandatory exercise therapy in patients with mild to moderate stroke and traumatic brain injury. The original version of the WMFT consisted of 21 items.

The widely used WMFT consists of 17 items. The first 6 items consist of timed functional tasks, items 7 and 14 measure muscle strength, and the remaining 9 items consist of analyses of the quality of movement in accomplishing various tasks.
9 months
The motor activity log
Time Frame: 9 months

The motor activity log is a structured interview, designed to explore how and how well subjects are using the more affected arm outside of a laboratory setting. Participants are asked standardized questions about their high-impact arm usage (amount scale or AS) and quality of movement (how good scale or HW) during a specified functional activity. The scale is printed on a separate sheet and placed in front of the participant during test administration.

Participants should be told that they can give half marks (i.e. 0.5, 1.5, 2.5, 3.5, 4.5) if this reflects their assessment.
9 months
The Ashworth scale,
Time Frame: 9 months
The Ashworth scale, which rates each passive movement between 1 (normal) and 5 (immobility), was used in a recent study and is easier to use than other methods and applicable to wide-range movements.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Zeest hashmi, MSNMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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