| CTRI Number |
CTRI/2024/12/078706 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Benefits of Front walking Versus Backward Walking on Pain, Joint Position Sense and Daily Activities in Patients with Neck Pain |
|
Scientific Title of Study
|
Effect of Forward Versus Backward Walking Combined with Virtual Reality on Pain, Proprioception and Functional Disability in Individuals with Non-Specific Neck Pain: A Randomized Clinical 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 |
Dr. Swaraj Kale |
| Designation |
post graduate student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY, BELAGAVI |
| Address |
Advanced physiotherapy centre, Room No. 39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8669774249 |
| Fax |
|
| Email |
swarajkale3369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vijay Kage |
| Designation |
Dean and Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy centre, Room No. 39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Advanced physiotherapy centre, Room No. 39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vijay Kage |
| Designation |
Dean and Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy centre, Room No. 39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Advanced physiotherapy centre, Room No. 39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLEs DR. Prabhakar Kore hospital and medical research centre, Nehru Nagar, Belagavi, 590010, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education And Research |
| Address |
Nehru Nagar, Belagavi, Karnataka, India, 590010. |
| 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 Swaraj Kale |
KLEs DR.Prabhakar kore hospital and medical research centre. |
Advanced physiotherapy centre, Room No. 39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
8669774249
swarajkale3369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLEs DR.Prabhakar kore hospital and medical research centre, belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Backward Walking |
Backward walking on treadmill with virtual reality will be given for 15 mins along with conventional treatment (i.e., exercises for neck and electrotherapy modality) for 5 days |
| Intervention |
Forward walking |
Forward walking on treadmill with virtual reality will be given for 15 minutes along with conventional treatment (i.e., exercises for neck and electrotherapy modality) for 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All genders of age 18 to 40 years.
Having neck pain for 2-4 weeks.
Pain intensity more than 3 on VAS.
The ability to independently walk without any external aid.
Willing to participate in study.
Willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
If present with any serious pathology such as specific neck pain due to disc prolapse, tumor of cervical spine, whiplash injury, cervical fractures, or cervicogenic headache.
Neurological signs of nerve root compression.
Recent fracture of spine and lower limb.
Recent injury to lower limb and Amputation
Impaired balance
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck disability index for functional deformities, Visual Analogue Scale for pain rating and Cervical Joint Position Sense Error test for joint position sense |
1st day and 5th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
27/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aim: To determine the effect of forward walking versus backward
walking combined with VR on pain, proprioception, and functional disability in
individuals with non-specific neck pain.
Inclusion criteria
1) All genders of age 18 to 40
years.
2) Having neck pain for 2-4 weeks.
3) Pain intensity more than 3 on VAS.
4) The ability to independently walk without any external aid.
5) Willing to participate in study.
Exclusion criteria
1) If present with any serious pathology such as specific neck pain due
to disc prolapse, tumor of cervical spine, whiplash injury, cervical fractures,
or cervicogenic headache.
2) Neurological signs of nerve root compression.
3) Recent fracture of spine and lower
limb.
4) Recent injury to lower limb and
Amputation
5) Impaired balance
Outcome measures
1) Assessment
of neck pain using Visual Analogue Scale
2) Assessment
of neck functional disability using Neck disability Index
3) Assessment
of neck position sense using the cervical joint Position Sense Error test
Procedure: The study participants
will then be randomly allocated into two different groups. Group A will be
administered with forward walking + conventional treatment and group B will be
administered with backward walking + conventional treatment
|