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Immediate Effect of One-session MRT in Hemiparetics

Primary Purpose

Hemiparesis;Poststroke/CVA, Satisfaction, Patient

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Matrix-Rhythm Therapy
Conventional physiotherapy and rehabilitation
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis;Poststroke/CVA

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • to have single-sided hemiparesis for the first time,
  • to have hemiparesis at least four weeks earlier,
  • to have Modified Rankin Score of ≤3

Exclusion Criteria:

  • to use a cardiac pacemaker,
  • to have communication problems,
  • to have other neurological, psychiatric and/or orthopedic problems other than hemiparesis.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MRT group

Control group

Arm Description

One session Matrix-Rhythm Therapy

One session routine, conventional physiotherapy and rehabilitation

Outcomes

Primary Outcome Measures

Motricity Motor Scale
Index for motor impairment after stroke
Trunk Impairment Scale
It consists of 3 subscales of static and dynamic sitting balance and trunk coordination
The Box and Block Test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.
The Nine-Hole Peg Test
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible.
Treatment Satisfaction Scale
The amount of satisfaction that a patient feels ranges across a continuum from none (0) to an extreme amount of satisfaction (10).

Secondary Outcome Measures

Global Rating of Change Scale
Global Rating of Change (GRC) scales provide a means of measuring self-perceived change in health status.

Full Information

First Posted
September 22, 2021
Last Updated
January 26, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05062746
Brief Title
Immediate Effect of One-session MRT in Hemiparetics
Official Title
Immediate Effect of One-session Matrix Rhythm Therapy on the Functional Status and Treatment Satisfaction of Hemiparetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Immediate effect of one-session Matrix Rhythm Therapy on the functional status and treatment satisfaction of hemiparetic patients will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis;Poststroke/CVA, Satisfaction, Patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRT group
Arm Type
Experimental
Arm Description
One session Matrix-Rhythm Therapy
Arm Title
Control group
Arm Type
Other
Arm Description
One session routine, conventional physiotherapy and rehabilitation
Intervention Type
Other
Intervention Name(s)
Matrix-Rhythm Therapy
Intervention Description
One session Matrix-Rhythm Therapy will be applied to affected body parts.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy and rehabilitation
Intervention Description
Hemiparetics wil receive one session conventional physiotherapy and rehabilitation.
Primary Outcome Measure Information:
Title
Motricity Motor Scale
Description
Index for motor impairment after stroke
Time Frame
5 minutes
Title
Trunk Impairment Scale
Description
It consists of 3 subscales of static and dynamic sitting balance and trunk coordination
Time Frame
10 minutes
Title
The Box and Block Test
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.
Time Frame
2 minutes
Title
The Nine-Hole Peg Test
Description
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible.
Time Frame
2 minutes
Title
Treatment Satisfaction Scale
Description
The amount of satisfaction that a patient feels ranges across a continuum from none (0) to an extreme amount of satisfaction (10).
Time Frame
30 sec.
Secondary Outcome Measure Information:
Title
Global Rating of Change Scale
Description
Global Rating of Change (GRC) scales provide a means of measuring self-perceived change in health status.
Time Frame
30 sec.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: to have single-sided hemiparesis for the first time, to have hemiparesis at least four weeks earlier, to have Modified Rankin Score of ≤3 Exclusion Criteria: to use a cardiac pacemaker, to have communication problems, to have other neurological, psychiatric and/or orthopedic problems other than hemiparesis.
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey

12. IPD Sharing Statement

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Immediate Effect of One-session MRT in Hemiparetics

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