Outcome Measures of Modified Constraint Induced Movement Therapy Versus Dual Task Training on Upper Extremity and Cognitive Functions in Patients With Hemiparesis

July 18, 2024 updated by: Ahmed Alshimy
All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients were classified randomly into three equal groups, Study group A (GA) receiving modified constraint induced movement therapy in addition to conventional physical therapy program, Study group B (GB) receiving dual task training in addition to conventional physical therapy program and control group C (GC) receiving only conventional physiotherapy program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • Menoufia
      • Sadat, Menoufia, Egypt
        • Al Ryada University for Science and Technology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with age range between 55 and 65 years old.
  • The patients were from both genders (males &females).
  • Patients were of duration of illness between 6 and 12 months.
  • The patients were scoring 1 &1+ on modified Ashworth scale (mild spasticity).
  • The patients were of good ability to see and hear.
  • Consent form was obtained from all participants to approve the study and follow the commands.
  • All patients were scoring more than 26 on MMSE. All patients were medically stable.

Exclusion Criteria:

  • patients with moderate and sever spasticity.
  • patients with cognitive disorder due to other cause rather than spasticity.
  • patients with unstable medical conditions.
  • patients with previous or recurrent stroke.
  • patients with respiratory problems.
  • patients with shoulder dislocation or subluxation or frozen shoulder.
  • patients with uncontrolled hypertension, diabetes mellitus, unstable angina or heart failure.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Receiving modified constraint induced movement therapy , for 30 minutes , in addition to conventional physiotherapy program for the other 30 minutes.
Other: Modified Constraint Induced Movement therapy
patient wears a restraint instrument in his unaffected hand, then applying massed practice to his affected upper extremity. The patient wears padded glove in his unaffected upper extremity for restraining the patient from using his unaffected upper extremity for about 3 hours per day including the treatment session and the home program. So, by this way the patient is reinforced to use his affected upper extremity during this period of time to achieve his activities of daily living. Finally, the total time, the patient spends it during the day wearing the glove should be recorded each day.
Other: Conventional physiotherapy rehabilitation program
Ultrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles
Experimental: Group B
Receiving dual task training (Cognitive-Motor) for 30 minutes, in addition to conventional physiotherapy program for the other 30 minutes.
Other: Conventional physiotherapy rehabilitation program
Ultrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles
Other: Dual task training in the form of cognitive - motor task
Verbal fluency: Ask the hemiparetic patient to title many words of specific type as fruits, vegetable or animals. Mental tracking: as the hemiparetic patient to subtract serial 3 between number 90 and 100.
Other: Group C
Receiving only conventional physiotherapy program for 60 minutes.
Other: Conventional physiotherapy rehabilitation program
Ultrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biodex isokinetic dynamometer
Time Frame: 4 weeks
Used to assess muscle strength and function
4 weeks
Montreal cognitive assessment
Time Frame: 4 weeks
a quick test that is used to examine mild cognitive impairment and early dementia.
4 weeks
Fugl Myer upper extremity
Time Frame: 4 weeks
a scale used to measure the functional impairment of stroke
4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahmed Alshimy

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005007

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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