Effects of CIMT in Parkinson's Disease Patients
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Constraint Induced Movement Therapy and Routine Physical Therapy
Routine Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Constraint induced movement therapy, Upper limb, Physical therapy, Exercise
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with Parkinson's disease referred from neurology department.
- Parkinson's disease patients with age range 50- 80 years.
- Both male and female patients.
Exclusion Criteria:
- Atypical Parkinsonism Alzheimer's disease
- Any patient taking antidepressants other than Parkinson's
- Patients of severe cognitive impairments.
Sites / Locations
- University of Lahore Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Constraint Induced Movement Therapy and Routine Physical Therapy
Routine Physical Therapy
Arm Description
Patients received constrained induced movement therapy and routine physical therapy for up to 6 hrs/day, 5 days/week for 4 weeks.
Patients received routine physical therapy for 5 days/week for 4 weeks.
Outcomes
Primary Outcome Measures
Frenchay Arm Test
The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during ADL performance in patients with impairments of upper extremity resulting from neurological conditions. FAT is an upper extremity specific measure of activity limitation. The Frenchay Arm Test is an ordinal 2-point scale (0-1). 0 for fail and 1 for pass. A total of 5 points can be obtained (range 0-5) with better score demonstrating better performance. FAT took about 3 minutes to administer.
Secondary Outcome Measures
Full Information
NCT ID
NCT04818528
First Posted
March 23, 2021
Last Updated
March 25, 2021
Sponsor
University of Lahore
Collaborators
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04818528
Brief Title
Effects of CIMT in Parkinson's Disease Patients
Official Title
Effects of Constraint Induced Movement Therapy on Hand and Arm Functions in Patients of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
Collaborators
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
The purpose of the study was to determine the effects of constraint induced movement therapy on hand and arm functions in Parkinson's disease patients. It was a randomized controlled trial, conducted in physical therapy department of University of Lahore Teaching Hospital, Mayo Hospital and Lahore General Hospital. 40, male and female Parkinson's disease patients aged between 50-80 years were randomly allocated into two equal groups. In experimental group patients were treated with constraint induced movement therapy and routine physical therapy and in control group patients were treated with routine physical therapy. Patients were treated for a total of 4 weeks, 6 hours in a day. Patients were assessed using Frenchay Arm Test (FAT). SPSS 25 was used to analyze the data.
Detailed Description
One of the central nervous system's most frequent diseases is Parkinson's disease (PD). In individuals with PD upper limb impairments could be present such as resting tremor or micrographia, often the first symptom of the disorder. These upper limb conditions can lead to difficulties in work, leisure, and everyday activities such as eating and dressing as the disease advances. This research was aimed to provide insightful information for both clinicians, researchers and for community in general. This study was helpful in the field of neurorehabilitation to bridge the gaps of previous researches. Clinician or neurorehabilitation expert can apply the more useful technique on patients and get the better results in less time. Researchers can find the high-quality clinical evidence regarding constraint induced movement therapy on Parkinson's patients. According to evidence-based practice patient preference is considered in providing treatments to patients. So, patient can find out which treatment is better.
40 patients who fulfill the inclusion criteria were enrolled in this study. Written informed consent was taken from every subject participating in this study. Allocation of subjects in two groups was done by random number table. Group A was treated with Constrained Induced movement therapy along with routine physical therapy and group B was treated only with routine physical therapy. In routine physical therapy group patients received intervention according to systematic review and clinical guidelines that worked on aerobic capacity, muscle strengthening exercise, walking ability, postural and balance disorders and improving hand arm function.39 Three stages were used in each session: (i) warm-up phase: passive mobilization of major joints and lower limb muscle strengthening; (ii) active phase (both standing and sitting): motor control exercises for upper and lower limbs, and (iii) cool-down phase (in seating position): respiratory exercises and mobilization.
40 The routine or baseline therapy was remained same throughout the study. Constraint induced movement therapy was given to group A for four weeks. Training was done for 6 hrs/day, 5 days/week for 4 weeks. All the information wascollected by using standardized questionnaire of Frenchay arm test. Confounding variables were controlled by randomization and restriction methods. All treatment was given by single therapist to control the biasness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Constraint induced movement therapy, Upper limb, Physical therapy, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It was a parallel group, randomized controlled trial of 40 Parkinson's disease patients enrolled between December 2020 to Feb 2021.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Constraint Induced Movement Therapy and Routine Physical Therapy
Arm Type
Experimental
Arm Description
Patients received constrained induced movement therapy and routine physical therapy for up to 6 hrs/day, 5 days/week for 4 weeks.
Arm Title
Routine Physical Therapy
Arm Type
Active Comparator
Arm Description
Patients received routine physical therapy for 5 days/week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Constraint Induced Movement Therapy and Routine Physical Therapy
Intervention Description
Intensive, graded practice of the paretic upper limb to enhance task-specific use of the affected limb. Constraint or forced use therapy, with the non-paretic upper limb contained in a mitt to promote the use of the impaired limb during 90% of the total hours awake. Adherence enhancing behavioral methods designed to transfer the gains obtained in the clinical setting or the laboratory to patients' real-world environment (ie, a transfer package).
As part of routine physical therapy patients received intervention that worked on aerobic capacity, muscle strengthening exercise, walking ability, postural and balance disorders and improving hand arm function. Three stages were used in each session: (i) warm-up phase: passive mobilization of major joints and lower limb muscle strengthening; (ii) active phase (both standing and sitting): motor control exercises for upper and lower limbs, and (iii) cool down phase (in seating position): respiratory exercises and mobilization.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
As part of routine physical therapy patients received intervention that worked on aerobic capacity, muscle strengthening exercise, walking ability, postural and balance disorders and improving hand arm function. Three stages were used in each session: (i) warm-up phase: passive mobilization of major joints and lower limb muscle strengthening; (ii) active phase (both standing and sitting): motor control exercises for upper and lower limbs, and (iii) cool down phase (in seating position): respiratory exercises and mobilization.
Primary Outcome Measure Information:
Title
Frenchay Arm Test
Description
The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during ADL performance in patients with impairments of upper extremity resulting from neurological conditions. FAT is an upper extremity specific measure of activity limitation. The Frenchay Arm Test is an ordinal 2-point scale (0-1). 0 for fail and 1 for pass. A total of 5 points can be obtained (range 0-5) with better score demonstrating better performance. FAT took about 3 minutes to administer.
Time Frame
Change from Baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with Parkinson's disease referred from neurology department.
Parkinson's disease patients with age range 50- 80 years.
Both male and female patients.
Exclusion Criteria:
Atypical Parkinsonism Alzheimer's disease
Any patient taking antidepressants other than Parkinson's
Patients of severe cognitive impairments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Ghazanfar
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of CIMT in Parkinson's Disease Patients
We'll reach out to this number within 24 hrs