| CTRI Number |
CTRI/2024/03/064276 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
NDT(Bo-bath) and customized functional mobility exercises for incomplete spinal cord injury management |
|
Scientific Title of Study
|
Comparative Efficacy Of Neuro-Developmental Treatment (Bo-Bath – NDT) Versus Customized Functional Mobility Exercises With Orthosis In The Management Of Incomplete 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 |
Divya Khati |
| Designation |
Student |
| Affiliation |
Lovely Professional University |
| Address |
Department Of Physiotherapy, School Of Allied Medical Sciences
Kapurthala
PUNJAB
144411
India |
| Phone |
07906837165 |
| Fax |
|
| Email |
khatidivya10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Yashudas |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department Of Physiotherapy, School Of Allied Medical Sciences, Room No.4-213
Kapurthala
PUNJAB
144411
India |
| Phone |
9559216499 |
| Fax |
|
| Email |
yashudas.28609@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Khati |
| Designation |
Student |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, school of allied medical sciences
Kapurthala
PUNJAB
144411
India |
| Phone |
7906837165 |
| Fax |
|
| Email |
khatidivya10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi GT road, Phagwara, Punjab (India) - 144411 |
|
|
Primary Sponsor
|
| Name |
Divya Khati |
| Address |
Lovely Professional University Jalandhar-Delhi GT road, Phagwara, Punjab (India) - 144411 |
| 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 |
| Divya Khati |
Gurjot spinal Rehab and Physiotherapy Clinic |
Basement, SCO 100, Cool Road, Urban Estate, Jalandhar - 144022
Kapurthala
PUNJAB |
7906837165
khatidivya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University (IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S242||Injury of nerve root of thoracic spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Neurodevelopmental Treatment (Bobath) |
Neurodevelopmental Treatment Bo-Bath
Week 1 45 minutes per day • Proper positioning, body alignment, and postural tone
• Relaxed passive movements
• Facilitation of active movement pattern
• Turning and rolling bed mobility exercises
Week 2 45 minutes per day • Active positioning of head trunk and large joints
• Functional reach with postural movement
• Proximal and distal stabilization
Week3 45 minutes per day • Distal joint functional movement
• lower extremity active assisted exercises
• Engaged in activity with minimal assistance
Week4 45 minutes per day • Facilitation for improving muscle tone
• Goal-directed activity
• Facilitation for desired motor response
Week 5 45 minutes per day • Modified postural control with activity
• Inhibit the dysfunctional component of movement
• Facilitate missing components with a functional pattern
Week 6 45 minutes per day • Intermittent compression in sitting in B/L gluteus
• Facilitation of proprioceptive tactile stimulation of ankle and sole
• Weight-bearing in sitting and standing with the vestibular ball
• Weight-bearing and weight shifting
• Postural alignment
• Single-leg weight-bearing (progress to functional exercises starting from bed side sitting to standing and walking)
• Encourage more independent movement
plasticity and neural tissue plasticity.
The goal behind Bobath concept is to promote motor learning for efficient motor control in various conditions, thereby improving functioning. This treatment method is based on specific patient handling, by using commands and cues by the therapists, this will help and give direction to the patients to initiate and complete the functional tasks in a coordinated way. This treatment method is a multidisciplinary, involving physiotherapists, occupational therapists, and speech and language therapists. In United States, the Bobath concept is also known as Neuro-Developmental Treatment (NDT) |
| Comparator Agent |
group2- Customized functional mobility exercises with orthosis |
Customized functional mobility exercises with orthosis are unique physical activities made especially for a person to improve their mobility and make everyday tasks better. Functional mobility exercises are tailored to meet the patients specific needs and abilities. The therapist will design exercises that specifically address a persons challenges in functional performance. These exercises can improve patient’s strength, flexibility, and mobility which will make them functionally independent and will improve patient’s quality of life.
Treatment Duration - 6 weeks/day
Treatment Time - 45 minutes/day |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Incomplete spinal cord injury (level of injury – below T10, ASIA-C)
2. Age groups between 20-40 years
3. Both genders (male and female)
4. The patients clinically diagnosed as incomplete spinal cord injury will be included for this study
5. Poor trunk control
6. lower extremity weakness Incoordination Poor balance
|
|
| ExclusionCriteria |
| Details |
1. Comatose patients
2. Complete spinal cord injury
3. Medical instability
4. Any recent fracture or surgery
5. Recent myocardial infarction
6. Auditory impairment
• Perceptual defects
• Reflex sympathetic dystrophy
• Mental retardation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. ASIA ISNCSCI
2. Modified functional reach test
3. Spinal cord injury independence measure (SCIM)
4. Wheelchair skill test
5. Spinal cord injury functional ambulation inventory (SCI-FAI)
6. SF36 (short-form health survey) |
1. 3 times
2. 3times
3. 4 times
4. 3times
5. 2 times
6. 2 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="5"
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
|
This is a two-way experimental study, comparative in nature. In this study, we are comparing two different interventions neurodevelopment treatment (NDT) and customized functional mobility exercises in the management of spinal cord injury. the main objective of this study is to know which treatment is more effective and beneficial for patients with incomplete spinal cord injury to improve the functional mobility of the patient. convenient sampling will be followed for the sampling of the patients. 30 patients will be enrolled for this study as per their willingness and will be divided into two groups. Group 1- consists of 15 subjects who will be treated with neurodevelopmental treatment (Bobath), and Group 2- consists of 15 subjects who will be treated with customized functional mobility exercises with an orthosis. duration of intervention will be 6 weeks (6 days/week and 1 day home exercise. treatment time will be 45 minutes/day. primarily focusing on muscle strength, coordination, balance, and gait, OR overall functional independence and quality of life of the patients. |