| CTRI Number |
CTRI/2025/07/090112 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
“Does Adding Ankle Stability Exercises to Regular Physiotherapy Help Improve Neck Movement, Pain, Balance Awareness, and Daily Function in People with Long-Term Neck Pain?” |
|
Scientific Title of Study
|
Added effects of ankle stability exercises combined with standard physiotherapy protocol versus standard physiotherapy protocol alone on cervical mobility, pain, cervical proprioception and functional abilities in subjects with chronic non-specific neck pain: an experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashvi Shah |
| Designation |
MPTh Scholar |
| Affiliation |
K.J.Somaiya College Of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy, Musculoskeletal Department,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9930848089 |
| Fax |
|
| Email |
shahyashvi08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sneha Ganu(PT) |
| Designation |
PHD Scholar |
| Affiliation |
K.J.Somaiya College Of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy, Musculoskeletal Department, Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9820790250 |
| Fax |
|
| Email |
s.ganu@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Yashvi Shah |
| Designation |
MPTh Scholar |
| Affiliation |
K.J.Somaiya College Of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy, Musculoskeletal department,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9930848089 |
| Fax |
|
| Email |
shahyashvi08@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.J . Somaiya College of Physiotherapy mumbai Maharashtra India
400022 |
|
|
Primary Sponsor
|
| Name |
Yashvi Shah |
| Address |
KJ Somaiya college of physiotherapy, Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022 |
| 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 |
| Yashvi Shah |
K.J.Somaiya College Of Physiotherapy |
KJ Somaiya college of physiotherapy,musculoskeletal department Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA |
9930848089
shahyashvi08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ankle Stability exercises |
1. ankle strengthening exercises
2. Calf raises, single leg standing and squat
3. Walking in different patterns
4.heel and toe raises on different surfaces
5. Proprioceptive exercises
Total duration:40 mins for 2 weeks |
| Intervention |
Conventional Physiotherapy Exercises |
1. Hot packs will be given
2. Cervical isometrics
3. Trapezius stretching and levator scapulae stretching
4. Postural correction exercises- chin tucks, shoulder retractions, shoulder shrugs
5. Proprioceptive craniocervical exercises
Total duration: 30mins for 2 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 18 to 35 years with non-specific neck pain for at least 12 weeks, having a pain intensity of 3 to 7 on the Numerical Pain Rating Scale (NPRS), and who are willing to participate and provide informed consent will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Any diagnosed Vestibular disorders (e.g : vertigo, Meniere’s disease)
2.Any diagnosed Neurological condition affecting balance, proprioception, or motor control (eg : Peripheral neuropathy,Stroke, multiple sclerosis, or Parkinson’s disease)
3.Any musculoskeletal conditions affecting Neck,Upper limb and Lower Limbs such as
a)Cervical spondylosis,radiculopathy,Spondylolisthesis or cervical myelopathy
b)Cervical spinal surgeries
c)Any history of major trauma,injury and surgery to upper limb
d)Any history of major trauma,injury and surgery to lower
4. Participants who have undergone any form of structured physiotherapy or rehabilitation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain by Numerical Pain Rating Scale (NPRS)
2.Cervical range of motion (CROM) device:
3. Cervical Proprioception- Cervical Joint Position Sense Error Test
4. Neck Disability Index Scale |
Baseline and 2 weeks |
|
|
Secondary Outcome
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="1"
Months="6"
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
|
NEED OF STUDY - Chronic non-specific neck pain is often treated with localized physiotherapy, but emerging research suggests a connection between ankle stability and cervical function through the myofascial chain. This study explores whether adding ankle stability exercises to standard care improves neck pain, mobility, proprioception, and function. Enhancing postural control through distal joint intervention may offer a holistic, cost-effective approach to managing and preventing chronic neck pain
AIM - To assess the added effects of ankle stability exercises combined with standard physiotherapy protocol compared to standard physiotherapy protocol alone on cervical mobility, pain, cervical proprioception, and functional abilities in subjects with chronic non-specific neck pain
|