| CTRI Number |
CTRI/2024/09/073648 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cognitive exercise therapy for Improving upper limb functions in patients with Acquired Brain Injury. |
|
Scientific Title of Study
|
The efficacy of Neuro-Cognitive Therapeutic Interventions for improving upper extremity
functions in patients with Acquired Brain Injury – A double-blinded, parallel-arm, 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 |
V Ramya |
| Designation |
Occupational Therapist |
| Affiliation |
Christian Medical College |
| Address |
Occupational Therapy
Department of Physical Medicine and Rehabilitation
Christian Medical College
Occupational Therapy
Department of Physical Medicine and Rehabilitation
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
8148067886 |
| Fax |
|
| Email |
ramyaaav.24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V Ramya |
| Designation |
Occupational Therapist |
| Affiliation |
Christian Medical College |
| Address |
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
8148067886 |
| Fax |
|
| Email |
ramyaaav.24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samuelkamaleshkumar |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Head of Occupational Therapy Services
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College
Head of Occupational Therapy Services
Occupational Therapy section
Department of Physical Medicine and Rehabilitation
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
9894465407 |
| Fax |
|
| Email |
stopatsams@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Internal fluid research grant
Christian Medical College
Vellore 632004
Tamil Nadu
India
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College
Vellore
Tamil Nadu
India
632004 |
| 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 |
| Dr Henry Prakash |
Christian Medical College |
Occupational Therapy Section
Christian Medical College
Vellore 632004
Vellore
TAMIL NADU |
4162282158
henry@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interdisciplinary Rehabilitation Program |
Participants in the control group will undergo a patient-specific multidisciplinary rehabilitation program involving conventional occupational therapy, physical therapy, and speech therapy (if required) for 5 days, 6 hours/day, over 4 weeks. In this study, conventional occupational therapy administered will be based on the Occupational Therapy Practice Framework (OTPF3). The intervention will be comprised of passive joint exercises to reduce upper extremity spasticity and active activities targeting fine motor skills, micro-movements, and bilateral coordination. Neurodevelopmental treatment will be incorporated as appropriate to each patients recovery stage. Activities of Daily Living (ADL) will be assessed, including wheelchair operation, functional mobility, feeding, dressing, and personal hygiene. ADL tasks for each participant will be chosen based on their individual recovery level, focusing on enhancing functional independence through targeted practice. |
| Intervention |
NCTI
Neuro Cognitive Therapeutic Intervention |
The proposed intervention is a 5 days a week training program developed by the researcher, based on the Neuro-Cognitive rehabilitation theory. The intervention duration will be 45mins - 1 hour.
The experimental group will receive the NCTI during the occupational therapy session.
The training structure begins with a 10-minute warm-up session, during which the patients will engage in light aerobic exercises while watching a video that is played for them followed by an Activity session of (motor activities incorporating kinesthesia, proprioception, tactile, attention, concentration and memory).
Shoulder flexion and abduction: Photos will be taken of the patients performing these movements at various angles. The therapist will then ask the patient to perform the movements shown in the photos.
Shoulder/elbow joint angle perception with circular track plate: (identify joint angles and distances with eyes closed): The unaffected hand will first be passively guided through the plate with eyes open, and then the same will be done with eyes closed. Next, the affected hand will be passively guided through the circular plate with eyes open and the same will be performed with eyes closed. The patient will then be asked to explain the feeling.
Finger opening and closing ranges: 3-5 wooden blocks of different sizes will be marked as 1, 2, 3 and so on. With eyes open, the pieces will be held between the thumb and index finger. The same will be repeated with eyes closed. This will then be repeated with the affected hand. With eyes closed, a block will be given to the patient and they will be asked to recognize it.
Identification of resistance: Gel balls of different resistance will be marked as 1, 2 and 3. The patient will be asked to squeeze the balls (1, 2 and 3) with the unaffected hand with eyes open and repeat with eyes closed. The affected hand will then be assisted in squeezing the balls (1, 2 and 3) with eyes open and the same will be repeated with eyes closed. The patient will then be asked to explain the feeling and given a ball to try and recognize the type.
Block of same size and different weights: to recognize changes in weight: Blocks of different weights will be marked as 1, 2, 3 and so on. The weights will be compared with the unaffected hand. The same will be done with the affected hand to try and recognize the weights.
Tactile: tactile boards made with different textures: The patient will describe the textures with eyes closed. The unaffected hand will feel the textures with eyes open, then repeat with eyes closed to try and recognize the different textures.
Stereognosis: 5 recognizable objects (lock, comb, spoon, coin, brush) will be placed in front of the patient for them to try and recognize by touch. The unaffected hand will touch and feel the objects with eyes open, then repeat with eyes closed. The affected hand will then feel the objects with eyes open and repeat with eyes closed, attempting to recognize them.
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
inclusion criteria includes
1. Medically stable patients after final approval from the treating neurologist
2. Patients with Acquired Brain Injury presenting with hemiplegia and / or hemiparesis.
3. Less than 2 years since the onset of the stoke
4. Ability to follow 3 step commands
5. Sitting endurance for 30 mins.
6. Brunnstrom stage 3 and above
7. MMT minimum of grade 2 |
|
| ExclusionCriteria |
| Details |
the exclusion criteria includes
1. Secondary complications like T/C/D, heterotopic ossification.
2. Orthopedic conditions affecting upper limb functions.
3. Somatognosia and neglect
4. Modified Ashworth Scale 2 and above
5. Shoulder pain more than grade 6 on Numeric Pain rating scale (NRS)
6. Shoulder subluxation more than grade 2 in finger breadth grading scale. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To develop a Neuro-Cognitive Therapeutic Intervention protocol for patients.
with Acquired Brain Injury.
2. To find the efficacy of Neuro-Cognitive Therapeutic Interventions in improving
upper extremity functions. |
1. Baseline
2. After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find the efficacy of Neuro Cognitive Therapeutic Interventions in improving
ADL functions & cognition.
2. To find the therapists experience in performing the Neuro Cognitive
Therapeutic Interventions for patients with Acquired Brain Injury. |
Baseline
After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/09/2024 |
| 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 Applicable |
| 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
|
Motor and sensory impairments, particularly in upper limb function, are prevalent following Acquired Brain Injury (ABI) and often a primary focus of rehabilitation goals. Rehabilitation aims to promote motor recovery through various intervention techniques. A variety of techniques is used to address upper limb impairments post-ABI. Task-oriented training improves functional use of the affected limb, while splinting and casting support positioning, prevent contractures, and facilitate functional use. Constraint- induced movement therapy and mirror therapy leverage neuroplasticity principles to overcome learned non-use and promote cortical reorganization. Virtual reality provides engaging environments for practicing upper limb movements. Compensatory strategies and use of adaptive equipment are taught when functional recovery is limited. All of these methods have their own merits and demerits. One of the emerging interventions in the Upper limb Rehabilitation is Cognitive Exercise therapy (CET). CET focuses on retraining the perceptual and cognitive processes to facilitate upper extremity sensori-motor functions. It is based on the assumption that by training cognitive processes involved in perception, attention, memory, and learning, this will in turn support neuroplasticity changes and the recovery of upper extremity functions. However, research on finding the efficacy of CET on ABI patients is limited. This study aims to evaluate the efficacy of NCTI along with usual occupational therapy to improve upper extremity functions. The patients with ABI who are getting admitted in A2, Q3 wards and rehabilitation center, and who fulfill the inclusion criteria will be randomly divided into two groups as experimental group and control group. The patients in the control group will receive usual occupational therapy intervention for 2 hours per day. The patients in the experimental group will receive usual occupational therapy intervention for 1 hour and Neuro-Cognitive Therapeutic Interventions for 1 hour per day. Hence both groups will receive 2 hours of therapy per day, 5 days a week for 4 weeks. Both the groups will receive medical and other therapeutic interventions such as Physiotherapy, speech therapy etc as their regular interventions. |