| CTRI Number |
CTRI/2025/10/095891 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| 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 hip exercises to improve walking in Spinal Cord Injury |
|
Scientific Title of Study
|
Efficacy of Pelvic Proprioceptive Neuromuscular Facilitation (PNF) on Trunk Balance and Gait in Individuals with Traumatic Incomplete Paraplegia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal |
| Designation |
Master of Physiotherapy (MPT) in Neurology |
| Affiliation |
Lovely Professional University |
| Address |
Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
8699118053 |
| Fax |
|
| Email |
komalbacchan2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thiagarajan Subramanian |
| Designation |
Professor (PhD) and MPT |
| Affiliation |
Lovely Professional University |
| Address |
Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
9789247047 |
| Fax |
|
| Email |
strajanpt77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Komal |
| Designation |
Master of Physiotherapy (MPT) in Neurology |
| Affiliation |
Lovely Professional University |
| Address |
Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
8699118053 |
| Fax |
|
| Email |
komalbacchan2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab |
| Type of Sponsor |
Other [LPU, School of Allied Medical Science ] |
|
|
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 |
| Komal |
Lovely Professional University |
Block 3-105, Department of Physiotherapy, Lovely Professional University, Jalandhar-New Delhi GT Road, Punjab
Jalandhar
PUNJAB |
8699118053
komalbacchan2000@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: G958||Other specified diseases of spinalcord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Conventional therapy programs include exercise for body control combined with breathing and coughing techniques and strengthening, along with mat-based training and cardiovascular workouts.s.
Frequency: 3 sessions/week.
Duration:4 weeks (each session will leads ~45 minutes). |
| Intervention |
Pelvic PNF |
Pelvic PNF (Proprioceptive Neuromuscular Facilitation) techniques focusing on pelvic patterns to improve trunk balance and gait. The session will include pelvic PNF (AE-PD & PE-AD) and trunk muscle contraction. Frequency: 3 sessions per week; Duration: 4 weeks (each session will leads ~45 minutes) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with incomplete paraplegia due to SCI (Spinal Cord Injury) below the T6 (level of injury).
2. Patient walk with assistive device (e.g.sticks).
3. No other neurological conditions
4. Medically stable without complication |
|
| ExclusionCriteria |
| Details |
1. Age below 20 years and above 40 years
Injuries above T6 level
2. Non-ambulatory or complete dependent individuals
3. History of stroke, cerebral palsy, or muscular dystrophy
4. Presence of underlying conditions like cardiac disease, OA (osteoarthritis), and pressure ulcers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
For Trunk Balance— BBS (Berg Balance Scale), TUG (Timed Up and Go Test), mFRT (modified Functional Reach Test).
For Gait-FGA (Functional Gait Assessment), 3-MWT (3-Meter Walk Test)
Gait variables: stride length, cadence, and walking speed. |
Pre-intervention (before starting the procedure) and post-intervention (after 4 weeks of completion the procedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
22/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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
|
Spinal Cord Injury refers to damage to spinal cord tissue, which causes
deprivation of motor functions and sensory responses, along with dysfunction of
the autonomic nervous system in the area below the damaged location. Neurological
function preservation determines whether an SCI injury falls under the complete
or incomplete categories. Progressive spinal cord injuries damage only some
neural pathways to keep the lower part of the body active. This condition is
known as incomplete SCI. This study focused on subjects with spinal cord injuries below the T6
neurological level since these patients preserve upper body movements, which
enables concentrated trunk and leg therapy. Patients with T6 neurological
severity and below maintain upper body movement control; therefore, they can
better engage with pelvic P-PNF therapy to enhance trunk stability along with
walking abilities. The effectiveness of pelvic PNF
techniques has been observed in stroke and CP patients, but not enough research has been
conducted regarding its application in SCI rehabilitation for incomplete
paraplegics below T6. This investigation includes aims to determine the potential
advantages of P-PNF techniques in evaluating their benefits in this population. Participants will be randomly assigned to either the Experimental group (pelvic PNF) or the Control group (conventional physiotherapy) on the base of evalution. These group will teste by the outcome measures before starting the procedure (pre-intervention) and the end of the last visit of patients (post-intervention). The total time period of the procedusre is three days a week for four weeks. This investigation aims to
determine the potential advantages of P-PNF techniques in evaluating their benefits
in this population.
|