Back to resultsEffects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.
Primary Purpose
Hemorrhagic Stroke, Ischemic Stroke, Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
short-intensity modified CIMT and conventional therapy
conventional therapy alone
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Stroke focused on measuring Hemorrhagic Stroke, Ischemic Stroke, Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Riphah International UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
an experimental group receiving short-intensity modified CIMT and conventional therapy
a control group receiving conventional therapy alone.
Outcomes
Primary Outcome Measures
Wolf motor function test (WMF)
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.
The motor activity log
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.
The Ashworth scale,
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05916885
First Posted
June 14, 2023
Last Updated
June 27, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05916885
Brief Title
Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.
Official Title
Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine effects of short-intensity modified constraint-induced movement therapy on hand function in stroke patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke, Ischemic Stroke, Rehabilitation
Keywords
Hemorrhagic Stroke, Ischemic Stroke, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be allocated into two groups by randomization. The experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which patients will be given conventional therapy alone. The therapy regime will be 3 hours/ day, 5 days/week, and 4 successive weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
an experimental group receiving short-intensity modified CIMT and conventional therapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
a control group receiving conventional therapy alone.
Intervention Type
Other
Intervention Name(s)
short-intensity modified CIMT and conventional therapy
Intervention Description
an experimental group receiving short-intensity modified CIMT and conventional therapy
Intervention Type
Other
Intervention Name(s)
conventional therapy alone
Intervention Description
a control group receiving conventional therapy alone.
Primary Outcome Measure Information:
Title
Wolf motor function test (WMF)
Description
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.
Time Frame
9 months
Title
The motor activity log
Description
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.
Time Frame
9 months
Title
The Ashworth scale,
Description
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.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeest Hashmi, MS NMPT
Phone
03224655851
Email
zeest.hashmi@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
Imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeest Hashmi, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran I Amjad, PhD
Phone
03324390125
Email
Imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Fatima Chaudhry, MS NMPT
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35326973
Citation
Tedla JS, Gular K, Reddy RS, de Sa Ferreira A, Rodrigues EC, Kakaraparthi VN, Gyer G, Sangadala DR, Qasheesh M, Kovela RK, Nambi G. Effectiveness of Constraint-Induced Movement Therapy (CIMT) on Balance and Functional Mobility in the Stroke Population: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2022 Mar 8;10(3):495. doi: 10.3390/healthcare10030495.
Results Reference
background
PubMed Identifier
34459426
Citation
Uswatte G, Taub E, Lum P, Brennan D, Barman J, Bowman MH, Taylor A, McKay S, Sloman SB, Morris DM, Mark VW. Tele-rehabilitation of upper-extremity hemiparesis after stroke: Proof-of-concept randomized controlled trial of in-home Constraint-Induced Movement therapy. Restor Neurol Neurosci. 2021;39(4):303-318. doi: 10.3233/RNN-201100.
Results Reference
background
PubMed Identifier
29163334
Citation
Takebayashi T, Takahashi K, Moriwaki M, Sakamoto T, Domen K. Improvement of Upper Extremity Deficit after Constraint-Induced Movement Therapy Combined with and without Preconditioning Stimulation Using Dual-hemisphere Transcranial Direct Current Stimulation and Peripheral Neuromuscular Stimulation in Chronic Stroke Patients: A Pilot Randomized Controlled Trial. Front Neurol. 2017 Oct 30;8:568. doi: 10.3389/fneur.2017.00568. eCollection 2017.
Results Reference
background
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Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.
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