| CTRI Number |
CTRI/2024/04/066138 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of neurobic exercise in improving non dominant hand function in young adults |
|
Scientific Title of Study
|
Assessing the efficacy of neurobic exercise in optimising non dominant hand function in young adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Mehra |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9458976315 |
| Fax |
|
| Email |
mahiimamehra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar (PT) |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital
Department of Physiotherapy
North Block , Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9412468744 |
| Fax |
|
| Email |
drskumarmalik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Mehra |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital
Department of Physiotherapy
North Block , Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9458976315 |
| Fax |
|
| Email |
mahiimamehra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences , Pathribagh,Dehradun,
Uttarakhand,248001 |
|
|
Primary Sponsor
|
| Name |
Mahima Mehra |
| Address |
Shri Guru Ram Rai University,School of Paramedical and Allied Health Sciences, Pathribagh ,Dehradun,248001 |
| Type of Sponsor |
Other [[Self ]] |
|
|
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 |
| Mahima Mehra |
School of Paramedical and Allied Health Sciences |
Shri guru ram rai university , School of Paramedical and Allied Health Sciences Dehradun,248001
Dehradun
UTTARANCHAL |
09458976315
mahiimamehra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neurobic Exercise for both hand function. |
Intervention will be same .As a comparator we are giving the intervention to both hands.Duration of session - 35-40 minutes.Intervention will be given 4 days a week for 4 weeks. |
| Intervention |
Neurobics Exercise for non-dominant hand. |
Neurobic Exercises will be performed by non-dominant hand to give training to non-dominant hand function. Session is divided into two parts aiming to provide balanced comfortable and enjoyable way to stimulate brain.
Neurobic exercises session divided into two parts :- Part 1 (Writing exercises)- warm up to boost brain activity, An exercise worksheet is given that focuses on hand training and brain stimulation is provided throughout this session,iincludes four to five exercises, comprises writing words,letters,sentences,line diagrams,symbols and figures with some twist daily.Part 2 (Hand Exercises with different objects like ball,bottle,matchsticks,etc)
which will be further divided according to different levels.
Duration of session - 35-40 minutes.Intervention will be given 4 days a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age 20-25 years
Mini Mental State Examination (MMSE ≥ 24)
Both Males and Females
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Musculoskeletal disorder,
Neurological disorder,
Cognitive impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Jebsen Taylor Hand Function Test (JTHFT) |
1st day , 14th day , 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Box and Block Test |
1st day , 14th day , 28th day |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
21/05/2024 |
| 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="0"
Months="4"
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
|
Neurobic Exercises specifically designed to stimulate and challenge the brain , promoting mental agility , cognitive function , and overall brain health, thus improving physical function. Neurobics is used in enhancing non-dominant hand function stems from the profound impact of conditions like stroke , spinal cord injury , or amputation on the dominant limb leading to compromised upper extremity function and diminished quality of life. While existing research supports the efficacy of neurobic exercises in improving cognitive , there is noticeable gap in understanding their potential benefits for the hand function, particularly non-dominant hand function. Investigating this aspect is vital for developing holistic rehabilitation strategies that comparatively address the rehabilitation needs of both hands, ultimately contributing to optimized functional independence overall well-being for individuals facing such conditions. |