Effects of CIMT in Parkinson's Disease Patients

NCT04818528 | Completed DMC

• 1 other identifier: REC/RCR&AHS/20/0214
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Constraint induced movement therapy; Upper limb; Physical therapy; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at 4 weeks

Study Arms (2)

Constraint Induced Movement Therapy and Routine Physical Therapy

EXPERIMENTAL

Patients received constrained induced movement therapy and routine physical therapy for up to 6 hrs/day, 5 days/week for 4 weeks.

Other: Constraint Induced Movement Therapy and Routine Physical Therapy

Routine Physical Therapy

ACTIVE COMPARATOR

Patients received routine physical therapy for 5 days/week for 4 weeks.

Other: Routine Physical Therapy

Interventions

Constraint Induced Movement Therapy and Routine Physical Therapy OTHER

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.

Constraint Induced Movement Therapy and Routine Physical Therapy

Routine Physical Therapy OTHER

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.

Routine Physical Therapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Atypical Parkinsonism Alzheimer's disease
• Any patient taking antidepressants other than Parkinson's
• Patients of severe cognitive impairments.

Sponsors & Collaborators

• University of Lahore: lead
• Riphah International University: collaborator

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Mariam Ghazanfar

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: It was a parallel group, randomized controlled trial of 40 Parkinson's disease patients enrolled between December 2020 to Feb 2021.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: December 28, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 3, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)