Clinical trial NCT04818528: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Constraint induced movement therapy
Upper limb
Physical therapy
Exercise
Lead sponsor: University of Lahore
Sponsor class: OTHER
Collaborators: name: Riphah International University
First posted: 2021-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It was a parallel group, randomized controlled trial of 40 Parkinson's disease patients enrolled between December 2020 to Feb 2021.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Frenchay Arm Test
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Mariam Ghazanfar
role: PRINCIPAL_INVESTIGATOR
References: