Parkinson DiseaseNCT04884646
Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease.
A study testing VR with Routine physical therapy and Virtual reality, Motor Imagery with Routine physical therapy and Routine physical therapy in people with Parkinson Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease. 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?
- VR with Routine physical therapy and Virtual reality, Motor Imagery with Routine physical therapy and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 12 Jun 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
- Idiopathic Parkinson's disease
- Modified Hoehn and Yahr Scale(H\&Y stages I to III)
- Between the ages of 50 and 80 years of both genders
- Independent in transfers
- A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
- Previous lack of participation in balance or motor training.
Who cannot join
- History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
- History of orthopedic issues such as pain, fracture, or lower limb pathology,
- History of visual abnormalities,
- History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
- The participants having severe dyskinesia or "on-off" phases,
- Previous history of surgery for PD,
- History of virtual games used for treatment in the past three months, and
- Virtual game phobia.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 3800
About this study
Official title: Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease: A Randomised Controlled Trial
The aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease.
Read the detailed description
Parkinson's disease is one of the most common, insidious neurological disorders with major motor symptoms, including bradykinesia, resting tremors, rigidity, and postural disorders. Virtual reality and motor imagery are among the more innovative techniques for rehabilitation of patients with Parkinson's disease that promote motor learning through both explicit and implicit processes.This study is unique in that it examines the effects of VR versus MI on motor skills, balance, and daily living activities in individuals with Parkinson's disease
- Conditions
- Parkinson Disease
- Being tested
- VR with Routine physical therapy and Virtual reality, Motor Imagery with Routine physical therapy, Routine physical therapy
- Keywords
- Parkinson, Virtual Reality, Motor Imagery, Routine Physical Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR with Routine physical therapy and Virtual realityOther
Also called Rehabilitation following VR with Routine physical therapy treatment
VR group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks
Motor Imagery with Routine physical therapyOther
Also called Rehabilitation following MI with Routine physical therapy treatment
MI group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks
Routine physical therapyOther
Also called Rehabilitation following Routine physical therapy treatment
Group A will be given routine physical therapy in 40-min sessions and 20 min of walking and cycling with a short period of rest, every alternate day (3 days per week) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality with Routine Physical Therapy | Experimental | The duration of the VR will be from 10 to 15 minutes during each session and Routine Physical Therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training) Receives: Other: VR with Routine physical therapy and Virtual reality |
| Motor imagery technique with Routine Physical Therapy | Experimental | Motor Imagery techniques will be given for 5 to 10 minutes along with routine physical therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training) Receives: Other: Motor Imagery with Routine physical therapy |
| Routine Physical Therapy | Experimental | Only routine physical therapy will be given (including warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training) Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's disease Rating Scale Part II
This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales: Sub-scale II comprises the evaluation of activities in daily living. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability .
Measured: 3 months
Unified Parkinson's disease Rating Scale Part III
This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales and sub-scale III evaluates the motor system. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability
Measured: 3 months
Berg Balance Scale (BBS)
The scale has been established as the most widely used assessment tool in clinical settings to identify changes in balance performance. A score of less than 45 is considered a limit for the risk of falling, while a score of 56 relates to functional balance
Measured: 3 months
Secondary outcomes (1)
Activities-specific Balance Confidence Scale (ABC):
This scale is used as a predictor of falls in patients with neurological deficits. Patients are rated from 0% to 100%, with 0% interpreted as not at all safe and 100% as completely safe
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 May 2020
- Primary completion12 Jun 2021
- Study completion12 Jun 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 Riphah International UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884646
- Sponsor's protocol ID
- REC/Fsd/0115
- Status last verified
- Jun 2021
- First submitted
- 7 May 2021
- Last updated
- 16 Jun 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04884646
- Acronym / sponsor ID
- REC/Fsd/0115
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Virtual Reality, Motor Imagery, Routine Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 13 May 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 aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease.
Detailed description
Parkinson's disease is one of the most common, insidious neurological disorders with major motor symptoms, including bradykinesia, resting tremors, rigidity, and postural disorders. Virtual reality and motor imagery are among the more innovative techniques for rehabilitation of patients with Parkinson's disease that promote motor learning through both explicit and implicit processes.This study is unique in that it examines the effects of VR versus MI on motor skills, balance, and daily living activities in individuals with Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality with Routine Physical Therapy | Experimental | Other: VR with Routine physical therapy and Virtual realityThe duration of the VR will be from 10 to 15 minutes during each session and Routine Physical Therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training) |
| Motor imagery technique with Routine Physical Therapy | Experimental | Other: Motor Imagery with Routine physical therapyMotor Imagery techniques will be given for 5 to 10 minutes along with routine physical therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training) |
| Routine Physical Therapy | Experimental | Other: Routine physical therapyOnly routine physical therapy will be given (including warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic Parkinson's disease
- Modified Hoehn and Yahr Scale(H\&Y stages I to III)
- Between the ages of 50 and 80 years of both genders
- Independent in transfers
- A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
Key exclusion criteria (8 listed)
- History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
- History of orthopedic issues such as pain, fracture, or lower limb pathology,
- History of visual abnormalities,
- History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
- The participants having severe dyskinesia or "on-off" phases,
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 |
|---|---|---|
| VR with Routine physical therapy and Virtual realityAlso: Rehabilitation following VR with Routine physical therapy treatmentVR group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks | Other | Virtual Reality with Routine Physical Therapy |
| Motor Imagery with Routine physical therapyAlso: Rehabilitation following MI with Routine physical therapy treatmentMI group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks | Other | Motor imagery technique with Routine Physical Therapy |
| Routine physical therapyAlso: Rehabilitation following Routine physical therapy treatmentGroup A will be given routine physical therapy in 40-min sessions and 20 min of walking and cycling with a short period of rest, every alternate day (3 days per week) for 12 weeks | Other | Routine Physical Therapy |
Primary outcome
Unified Parkinson's disease Rating Scale Part II
Time frame: 3 months
This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales: Sub-scale II comprises the evaluation of activities in daily living. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability .
Unified Parkinson's disease Rating Scale Part III
Time frame: 3 months
This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales and sub-scale III evaluates the motor system. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability
Berg Balance Scale (BBS)
Time frame: 3 months
The scale has been established as the most widely used assessment tool in clinical settings to identify changes in balance performance. A score of less than 45 is considered a limit for the risk of falling, while a score of 56 relates to functional balance
1 secondary outcome
Activities-specific Balance Confidence Scale (ABC):
Time frame: 3 months
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 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR with Routine physical therapy and Virtual reality, Motor Imagery with Routine physical therapy and Routine physical therapy in people with Parkinson Disease, run by Riphah International University 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 6 inclusion and 8 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 16 Jun 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?
Unified Parkinson's disease Rating Scale Part II (time frame: 3 months). The study lists 3 primary outcomes in all. 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 16 Jun 2021.