| CTRI Number |
CTRI/2024/04/065904 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Brain gym exercise plays a role in improving cognition and ambulation in Duchenne Muscular Dystrophy |
|
Scientific Title of Study
|
Role of Brain Gym exercise to improve cognition and ambulatory function in patients with
Duchenne muscular dystrophy: Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. B316, Department of Physiotherapy,Galgotias University,
Plot No. 02, Sector 17-A Yamuna Expressway, Greater
Noida,Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himadri Saket |
| Designation |
PG Student |
| Affiliation |
Galgotias University |
| Address |
Room No. B-319, Department of Physiotherapy, Galgotias
University, Plot No. 02, Sector 17-A, Yamuna Motorway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7073186843 |
| Fax |
|
| Email |
himadrisaket@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. B316, Department of Physiotherapy, Galgotias University,
Plot No. 02, Sector 17-A Yamuna Expressway, Greater
Noida,Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Room No. C-102, Galgotias University, Plot No. 02, Sector 17-A, Yamuna
Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh-201301
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias University, Plot No.2, Sector 17-A Yamuna Expressway,
Greater Noida,Gautam Buddh Nagar, Uttar Pradesh 203201
|
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Jyoti Sharma |
Galgotias University |
Physiotherapy OPD, School of Allied Health Sciences, Room No. E003,
Galgotias University,
Plot No. 02, Sector
17-A, Yamuna
Expressway, Greater
Noida,Gautam Buddh
Nagar, Uttar
Pradesh-203201
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9717161626
jsharmaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q872||Congenital malformation syndromespredominantly involving limbs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain gym exercise and conventional physical therapy in Duchenne Muscular Dystrophy patients. |
Hook-ups, Brain buttons, Lazy 8s, Energy yawn, Calf pumps, Ear pull, Cross crawl with hand on shoulder, Modified hook-ups were used for brain gym exercises, approximately each exercise lasting for 5 minutes. The conventional physical therapy given along with brain gym exercise included memory games for 4-5 minutes, static bicycling for 4-5 minutes, and active assisted
ROM exercises for 7-8 repetitions for all joints for approximately 7-8 minutes, passive stretching of quadriceps, hamstrings, calves, chest, and back for 7-8 repetitions with a 15–30 second hold for approximately 7-8 minutes; functional activities like sit-to-stand and walking with assistance for 7-8 minutes; and respiratory exercises for 7-8 minutes.The total duration of the intervention will be approximately 76–82 minutes. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Only the Early Ambulatory stage of Duchenne Muscular Dystrophy patients
Patients with FSIQ score greater than 90 (average FSIQ score or more)
Parents give consent on behalf of the child in the English language, and able to speak and write in the English language.
|
|
| ExclusionCriteria |
| Details |
Late and Transitional stages of Duchenne Muscular Dystrophy patients
Patients with FSIQ score less than 90 (below average FSIQ score or more)
Parents are unable to speak and write in the English language.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini-mental-scale examination (MMSE) for cognition and North Star Ambulatory Assessment (NSAA) for ambulatory function. |
Assessment on the first day, followed by 2, 4, 8, and 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Full-scale Intelligence Quotient (FSIQ) for cognition |
Assessment on the first day, followed by 2, 4, 8, and 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/04/2024 |
| Date of Study Completion (India) |
12/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Duchenne muscular dystrophy (DMD) is primarily characterised by progressive muscle weakness and degeneration with climbing stairs, a waddling gait, and frequent falls. The symptoms mainly affect cognitive function and ambulation due to the involvement of dystrophin protein, which is essential for muscle and brain function. DMD patients present with these symptoms around 2–3 years of age and most patients become wheelchair dependent around 10–12 years of age and need assisted ventilation at around 20 years of age.Cognitive impairment in DMD can manifest as learning difficulties, attention deficits, and intellectual disability, while ambulatory function impairment often results from muscle weakness and progressive loss of mobility.The classification of Duchenne Muscular Dystrophy (DMD) typically involves staging the progression of the disease based on functional abilities, muscle strength, and mobility. It can be classified into early ambulatory, transitional, and late ambulatory phases, along with the advanced progression of the disease. Brain gym exercises, also known as educational kinesiology or brain-based learning, are a set of movements and activities designed to stimulate brain function and enhance cognitive abilities. These exercises aim to integrate the body and mind, improve focus, concentration, memory, and overall learning efficiency. Hooks-ups, modified hook-ups, brain buttons, lazy 8s, ear pulls, energy yawns, calf pumps, and cross crawls with hands on shoulders are a few brain gym exercises found to be effective in patients with cognitive impairment.
Physiotherapy plays a vital role in managing the symptoms of DMD by preserving muscle function, improving mobility, and addressing respiratory complications. It includes a combination of therapeutic exercises, stretching, positioning, and respiratory interventions.Integrating brain gym exercises into physiotherapy interventions can further enhance cognitive function, ambulatory function, and motor skills, ultimately improving the quality of life for individuals living with DMD.With the evolving concept of brain gym exercises to improve cognition and function in children, the scope of brain gym exercises in DMD can be focused on this study to improve cognition and ambulatory function. |