| CTRI Number |
CTRI/2024/10/075261 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2026 |
| 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
|
Effect of respiratory muscle facilitation technique on respiratory muscle strength in spinal cord injury individuals |
|
Scientific Title of Study
|
Effect of respiratory muscle proprioceptive neuromuscular facilitation on respiratory muscle strength in spinal cord injury individuals |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Negi |
| Designation |
Post graduate student (master of physiotherapy) |
| Affiliation |
Indian spinal injuries center-institute of rehabilitation sciences |
| Address |
Indian spinal injuries center,institute of rehabilitation sciences,rehabilitation department 2nd floor sector-C,vasant kunj,south delhi-110070
South
DELHI
110070
India |
| Phone |
9891330585 |
| Fax |
|
| Email |
negimansi05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shambhovi Mitra |
| Designation |
Associate professor |
| Affiliation |
Indian spinal injuries center-institute of rehabilitation sciences |
| Address |
Indian spinal injuries center,institute of rehabilitation sciences,rehabilitation department 2 nd floor sector-C,vasant kunj,south delhi-110070
South
DELHI
110070
India |
| Phone |
9711968166 |
| Fax |
|
| Email |
shams.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Shambhovi Mitra |
| Designation |
Associate professor |
| Affiliation |
Indian spinal injuries center-institute of rehabilitation sciences |
| Address |
Indian spinal injuries center,institute of rehabilitation sciences,rehabilitation department 2 nd floor sector-C,vasant kunj,south delhi-110070
South
DELHI
110070
India |
| Phone |
9711968166 |
| Fax |
|
| Email |
shams.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian spinal injuries center-institute of rehabilitation sciences,sector-C,vasant kunj,south delhi-110070,india |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Mansi Negi |
Indian spinal injuries center |
Indian spinal injuries center, institute of rehabilitation sciences, rehabilitation department 2nd floor sector-C, vasant kunj, south delhi-110070
South
DELHI |
9891330585
negimansi05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Indian spinal injuries center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S142||Injury of nerve root of cervical spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Proprioceptive Neuromuscular Facilitation and Inspiratory Muscle training |
Individuals under this group will recieve inspiratory muscle and proprioceptive neuromuscular facilitation training
Inspiratory muscle training will be given by threshold inspiratory muscle trainer device having
Frequency: 3-5 sets of 12 breath, followed by 2 minutes of quiet breathing
Intensity : 30% of MIP. This setting is increased each week by 10% of measured pi max if tolerated otherwise increased by 5%.
Time : 4 days/week for 4 weeks along with Proprioceptive neuromuscular training which can be given by placing hand on different parts of the chest wall,having
Frequency:10-12 times per set for 3 sets in one session per day.
After each set, a 30-60 second rest period will be provided.
Time : 4 days/week for 4 weeks.
|
| Comparator Agent |
Sham training |
Individuals under this group will recieve sham training of Inspiratory muscle training
Frequency: 3-5 sets of 12 breath, followed by 2 minutes of quiet breathing
Intensity : 30% of MIP/PI max.
Time : 4 days/week for 4 weeks along with Proprioceptive neuromuscular training
Frequency: 10-12 times per set for 3 sets in one session per day.
After each set, a 30-60 second rest period will be provided.
Time : 4 days/week for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Tetraplegics (level of injury C5- C8)
2.ASIA Impairment scale-A and B
3.Medically stable as deemed by treating physician.
|
|
| ExclusionCriteria |
| Details |
1.History of lung disease (asthma, COPD, restrictive disease of lungs)
2.Recent Thoracic or abdominal surgery
3.Recent ribs fracture
4.Chest wall deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximum inspiratory pressure |
0 week(baseline/pre test) and 4th week (post test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maximum expiratory pressure
|
0 week(baseline/pre test) & 4th week (post test) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Spinal cord injury (SCI) can lead
to significant respiratory complications due to impaired function of
respiratory muscles. Proprioceptive neuromuscular facilitation (PNF) is a
rehabilitation technique used to strengthen these muscles, showing efficacy in various
populations, including those with COPD and weaning failure. While inspiratory
muscle training (IMT) has proven beneficial in patients with tetraplegia, the
combination of respiratory PNF and IMT on respiratory strength in SCI patients
remains unexplored. Study procedure After baseline assessment and
allocation of 20 quadriplegic subjects (C5-C8), participants will be
divided into two groups: the experimental group, which will receive inspiratory
muscle training (IMT) combined with respiratory muscle proprioceptive
neuromuscular facilitation (PNF) and conventional physiotherapy, and the
control group, which will receive sham training (PNF + IMT) along with
conventional physiotherapy.In the experimental group: IMT:
Participants will perform 3-5 sets of 12 breaths, followed by 2 minutes of
quiet breathing. The intensity will start at 30% of their maximum inspiratory
pressure (MIP/PI max) and will increase by 10% weekly, or by 5% if the higher
increase is not tolerated. The training will take place 4 days per week for 4
weeks. PNF: Participants will perform 10-12 repetitions per set,
for 3 sets per session. Each set will be followed by a 30-60 second rest
period. This will also be conducted 4 days per week for 4 weeks.In the control
group:Sham training (PNF + IMT): The same frequency, intensity, and time
frame will be followed as the experimental group, but using sham techniques
instead.The total session time will be approximately 30-40 minutes, and the
primary outcome, respiratory muscle strength, will be assessed using MIP and
MEP measurements. Assessment: Primary
Outcome: Respiratory muscle strength
(measured by MIP and MEP) using a respiratory pressure manometer. Statistical Analysis Plan:
Descriptive statistics will
summarize data. Depending on data distribution, independent t-tests or
Mann-Whitney U tests will compare groups, and paired t-tests or Wilcoxon
signed-rank tests will evaluate pre- and post-intervention differences.
Analysis will be performed using SPSS 21, with significance set at 5%.
|