| CTRI Number |
CTRI/2024/10/074832 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [OCCUPATIONAL THERAPY INTERVENTION] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Music as an intervention for improving hand functions in patients with Parkinsons Disease |
|
Scientific Title of Study
|
Music-based interventions for improving upper extremity functions in patients with Parkinsons Disease: A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Partha sarathi Mohanty |
| Designation |
P.G student |
| Affiliation |
Christian medical college |
| Address |
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College, Vellore- 632004
Tamil Nadu
India
Vellore
TAMIL NADU
632004
India |
| Phone |
09938751080 |
| Fax |
|
| Email |
parthasarathimohanty61587@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Samuel kamalesh kumar |
| Designation |
Professor |
| Affiliation |
Christian medical college |
| Address |
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College, Vellore- 632004
Tamil Nadu
India
Vellore
TAMIL NADU
632004
India |
| Phone |
09938751080 |
| Fax |
|
| Email |
stopatsams@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samuel kamalesh kumar |
| Designation |
Professor |
| Affiliation |
Christian medical college |
| Address |
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College, Vellore- 632004
Tamil Nadu
India
Vellore
TAMIL NADU
632004
India |
| Phone |
9894465407 |
| Fax |
|
| Email |
stopatsams@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College
Vellore
Tamil Nadu
632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College, Vellore- 632004
Tamil Nadu
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Partha sarathi Mohanty |
Christian medical college and hospital |
C-403, Acute inpatient occupational therapy unit, Department of Neurology,
Christian Medical College
Ranipet Campus
Vellore- 632517
Tamil Nadu
India
Vellore
TAMIL NADU |
09938751080
parthasarathimohanty61587@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD , CMC VELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Occupational Therapy |
Usual Occupational Therapy Group (90 minutes):
Functional Training Activities: Engage in exercises to improve bed mobility, strength, range of motion (ROM), balance through activities such as ball catching and throwing, and flexibility.
Education Sessions: Provide information on Parkinsons disease, its progression, and symptom management strategies, including energy conservation and fall prevention techniques.
Adaptive Equipment Training: Teach the use of tools that promote independence in daily activities, such as walkers, canes, and utensils with larger handles for better grip.
Environmental Modifications: Assess and adjust the home environment to enhance safety and accessibility, which may include installing grab bars, removing tripping hazards, and rearranging furniture for improved mobility.
Activities of Daily Living (ADL) Training: Focus on practicing essential tasks like dressing, bathing, cooking, and toileting by simplifying them, breaking them into manageable steps, and providing verbal cues.
Cognitive Skills Development: Implement exercises to enhance memory, attention, and problem-solving skills.
Psychosocial Support: Offer counseling, facilitate support groups, and use Cognitive Behavioral Therapy (CBT) to promote mental well-being.
Fine Motor Skills Development: Employ techniques and adaptive strategies to improve fine motor skills through hand function activities like pegboard tasks, dexterity exercises, buttoning clothing, manipulating small objects with tweezers, and using adaptive devices as needed. |
| Intervention |
Music-based intervention |
The music-based interventions include two main approaches: Patterned Sensory Enhancement (PSE) and Rhythmic Auditory Stimulation (RAS). Both methods aim to improve upper extremity movements and functional abilities through rhythmic auditory cues that motivate participants.
For the PSE group, the structure includes:
1. Warm-Up (5 minutes)
Participants begin with gentle stretches to enhance flexibility and deep breathing for relaxation, setting a focused tone for the session.
2. Patterned Sensory Enhancement (20 minutes)
This core activity involves upper extremity tasks guided by personalized rhythmic music from the FL Studio app, tailored to individual movement preferences. The musical complexities increase by 5% weekly, providing a gradual challenge that motivates participants and supports rehabilitation.
3. Cool-Down and Reflection (5 minutes)
Sessions end with cool-down exercises to relieve muscle tension and a reflective discussion, encouraging participants to share their experiences, enhancing community and support.
For the RAS group, the framework is similar:
1. Warm-Up (5 minutes)
Participants start with gentle stretches and deep breathing to prepare for activities.
2. Rhythmic Auditory Stimulation (20 minutes)
They perform upper extremity tasks guided by metronome beats from the FL Studio app, synchronized to their preferred movements. Rhythmic cues also increase by 5% each week, fostering skill enhancement.
3. Cool-Down and Reflection (5 minutes)
Sessions conclude with cool-down exercises and a discussion, allowing participants to share insights and challenges, enriching their experience.
Both interventions highlight musics effectiveness as a therapeutic tool, enhancing movement and supporting emotional well-being, providing a holistic rehabilitation approach for diverse participants. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Both genders
Hoehn & Yahr stage 2 or stage 3
Able to comprehend instructions (MoCA score more than 21)
Stable antiparkinsonian drug treatment in the past one month
Participants willing to give consent
Able to attend 1 week of hospital-based therapy sessions
Has a caregiver available to assist with setting up the home training environment for the 2-week home program |
|
| ExclusionCriteria |
| Details |
Presence of other neurological and orthopedic medical conditions that affect hand functions
Participants with any visual or auditory impairment
Participants engaged in other research studies involving music
Participants with complaints of migraine
Participants who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Gross Dexterity - Box and Block Test
2.Fine Dexterity - Purdue Peg Board Test
3.Hand Function - Action Research Arm Test |
1. Baseline
2. After 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ADL- MDS-UPDRS |
1. Baseline
2. After 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms that significantly impact an individual’s functional abilities and quality of life. Among the motor symptoms, upper limb dysfunctions, including impaired dexterity, coordination, and fine motor control, is a common and debilitating feature of PD. These deficits can have a profound impact on the performance of ADLs and self-care, leading to increased dependence and reduced independence. Existing rehabilitation approaches, such as Occupational Therapy, have focused on addressing these upper limb impairments through various therapeutic techniques and exercises. However, alternative approaches, such as Neurological music therapy (NMT), have gained increasing attention in recent years. NMT is a specialized form of music therapy that utilizes the therapeutic application of music to address sensory-motor, cognitive, and psycho-social needs associated with neurological disorders. Previous studies have demonstrated the efficacy of PSE and RAS in improving gait and upper limb function in individuals with neurological conditions, such as stroke and traumatic brain injury. However, their application and efficacy in improving upper limb function in individuals with PD have not been extensively explored. This study aims to compare the efficacy of PSE, RAS, and usual OT in improving upper limb functions in patients with PD. By evaluating the feasibility and effectiveness of these interventions, this study will contribute to the growing body of knowledge on the use of music-based interventions in the rehabilitation of PD patients. This will be a single-blinded, randomized controlled trial with three parallel arms: PSE group, RAS group, and usual OT group. The primary outcome measures will be the Box and Block Test, Purdue Peg board Test, and Action Research Arm Test. Secondary outcomes will include the Unified Parkinson’s Disease Rating Scale (UPDRS) for activities of daily living. Participants will be randomly allocated to receive either PSE with usual OT, RAS with usual OT, or usual OT alone for 3 weeks (1 week hospital-based and 2 weeks home-based). Assessments will be conducted at baseline and post-intervention. |