Parkinson DiseaseNCT04818528
Effects of CIMT in Parkinson's Disease Patients
A study testing Constraint Induced Movement Therapy and Routine Physical Therapy and Routine Physical Therapy in people with Parkinson Disease, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Constraint Induced Movement Therapy and Routine Physical Therapy and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Dec 2020to 3 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Atypical Parkinsonism Alzheimer's disease
- Any patient taking antidepressants other than Parkinson's
- Patients of severe cognitive impairments.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Constraint Induced Movement Therapy on Hand and Arm Functions in Patients of Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Constraint Induced Movement Therapy and Routine Physical Therapy, Routine Physical Therapy
- Keywords
- Constraint induced movement therapy, Upper limb, Physical therapy, Exercise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Movement Therapy and Routine Physical TherapyOther
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.
Routine Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start28 Dec 2020
- Primary completion2 Mar 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Riphah International University
- Responsible party
- Principal investigator, Mariam Ghazanfar, University of Lahore
- Investigators
- Mariam Ghazanfar, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818528
- Sponsor's protocol ID
- REC/RCR&AHS/20/0214
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Constraint Induced Movement Therapy on Hand and Arm Functions in Patients of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04818528
- Acronym / sponsor ID
- REC/RCR&AHS/20/0214
- Conditions
- Parkinson Disease
- Keywords
- Constraint induced movement therapy, Upper limb, Physical therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Riphah International University
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It was a parallel group, randomized controlled trial of 40 Parkinson's disease patients enrolled between December 2020 to Feb 2021.
| Arm | Type | Receives |
|---|---|---|
| Constraint Induced Movement Therapy and Routine Physical Therapy | Experimental | Other: Constraint Induced Movement Therapy and Routine Physical TherapyPatients received constrained induced movement therapy and routine physical therapy for up to 6 hrs/day, 5 days/week for 4 weeks. |
| Routine Physical Therapy | Active comparator | Other: Routine Physical TherapyPatients received routine physical therapy for 5 days/week for 4 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Atypical Parkinsonism Alzheimer's disease
- Any patient taking antidepressants other than Parkinson's
- Patients of severe cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constraint Induced Movement Therapy and Routine Physical TherapyIntensive, 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. | Other | Constraint Induced Movement Therapy and Routine Physical Therapy |
| Routine Physical TherapyAs 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. | Other | Routine Physical Therapy |
Primary outcome
Frenchay Arm Test
Time frame: Change from Baseline at 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam Ghazanfar principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Induced Movement Therapy and Routine Physical Therapy and Routine Physical Therapy in people with Parkinson Disease, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frenchay Arm Test (time frame: Change from Baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.