| CTRI Number |
CTRI/2024/10/075736 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
application based cognitive training for spinal cord injury individuals |
|
Scientific Title of Study
|
Comparison of Application-Based cognitive game
and Conventional Cognitive Training on Improving
Processing Speed, Attention and Memory in
Individuals with Spinal Cord Injury |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iffat Naseem |
| Designation |
Postgraduate student ( masters of physiotherapy) |
| Affiliation |
Indian spinal injury centre, Institute of rehabilitation sciences, |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor
Sector C, Vasant Kunj, new delhi.
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor
Sector C, Vasant Kunj, new delhi.
South
DELHI
110070
India |
| Phone |
9354012316 |
| Fax |
|
| Email |
iffatnaseem859@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Stuti Khanna |
| Designation |
Associate professor |
| Affiliation |
Indian spinal injury centre, Institute of rehabilitation sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor
Sector C, Vasant Kunj, New Delhi - 110070
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor
Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
110070
India |
| Phone |
9891847488 |
| Fax |
|
| Email |
sehgalstutiss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Iffat Naseem |
| Designation |
Postgraduate student ( masters of physiotherapy) |
| Affiliation |
Indian spinal injury centre, Institute of rehabilitation sciences, |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor
Sector C, Vasant Kunj, New Delhi.
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor
Sector C, Vasant Kunj, New Delhi.
South
DELHI
110070
India |
| Phone |
9354012316 |
| Fax |
|
| Email |
Iffatnaseem859@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, physcical medicine and rehabilitation department of neurorehabilitation, 2nd floor.
Sector C, Vasant Kunj, New Delhi - 110070
South West
|
|
|
Primary Sponsor
|
| Name |
Indian spinal injury centre, Institute of rehabilitation sciences |
| Address |
Sector C, Vasant Kunj, New Delhi, Delhi 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 0 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, indian spinal injury centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G825||Quadriplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive rehab via application based game (Lumosity) |
individual in the intervention group will receive cognitive rehab via lumosity application on laptop device for 20- 30 minutes a day, 3 times a week for 6 weeks. The following games will be used- assist ant, star search, familiar faces, highway hazard, masterpeices |
| Comparator Agent |
conventional cognitive training |
individual in the control group will receive conventional cognitive training via paper-and-pencil tasks and table top tasks, such as board games, puzzles, card games, and memory games for 20- 30 minutes a day, 3 times a week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Traumatic Spinal cord injury subject with 4-6
month after injury. 6
C5-T6 level of injury
Age 18-50 year.
Should not have previous experience of application
based cognitive games post injury.
Subject with basic knowledge of primary education. Should have bilateral index, Middle finger and
thumb function, specifically dominant hand.
MOCA (18-25-mild) |
|
| ExclusionCriteria |
| Details |
Participant with psychiatric disorders (post-traumatic stress disorder, schizophrenia, bipolar disorder) or neurological condition other than traumatic spinal cord injury as per medical record.
Known history of chronic alcohol consumption and
drug use.
Any Uncorrected hearing or visual impairment. • PHQ-9 ( 20- 27 severe ) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SDMT ( symbol digit modality test |
week 0 , after 3rd week & after completion of 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dual N-Back
Ebbinghaus Memory Test
Stroop interference Task Attentional Network Test
these task will be used by this software (PEBL is a free, open-source software system that allows researchers and clinicians to design, run, and share behavioral tests)
|
week 0 , after 3rd week & after completion of 6 week |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
It is estimated that 40-50% of individuals with spinal cord injuries experience cognitive impairments, with a 13-fold increased risk compared to non-injured individuals. Rehabilitation methods, including traditional tasks and application-based cognitive programs like Lumosity, have shown cognitive benefits across various populations. Modern technologies, such as app-based cognitive games, offer visual and auditory feedback, enhancing learning and motivation. They are convenient for home-based rehabilitation from a future perspective, potentially improving attention, memory, and processing speed. Despite evidence of benefits in other populations, there is a research gap regarding the impact of these games on cognitive functions in individuals with spinal cord injuries. Hence this research aims to the effectiveness of application-based games as an adjunct to conventional treatment for improving processing speed, attention and memory in individual with spinal cord injury Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. One group (Experimental group) will receive cognitive rehab via application-based game (Lumosity) for 3 times a week for 6 weeks. Whereas the second group (control group) will receive conventional cognitive training for the same duration. The outcome measurements will be done by SDMT (symbol digit modality test), and Dual N-Back, Ebbinghaus Memory Test, Stroop interference Task, Attentional Network Test by using PEBL software. Variations in the pre and post outcome measurements will help us find out the effectiveness of effectiveness of application-based games as an adjunct to conventional treatment for improving processing speed, attention and memory in individuals with SCI.
|