| CTRI Number |
CTRI/2025/08/093857 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Neck Movement and Quality of Life in People with Cervical Dystonia using Special Exercises and Pressure Biofeedback |
|
Scientific Title of Study
|
The Effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on improving Severity, Range of Motion and Quality of Life in patients with Chronic Cervical Dystonia A Pre Post Interventional 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 |
Dr Tanisha Mali |
| Designation |
Postgraduate Student |
| Affiliation |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7021643689 |
| Fax |
|
| Email |
tanishamali04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N. Ramesh |
| Designation |
HOD, Professor YMT college of physiotherapy |
| Affiliation |
Academic professor at YMT college of Physiotherapy, Dr. G. D. Pol Foundation |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
NIL
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7874856011 |
| Fax |
NIL |
| Email |
natraam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanisha Mali |
| Designation |
Postgraduate Student |
| Affiliation |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7021643689 |
| Fax |
|
| Email |
tanishamali04@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tanisha Mali |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210 |
| 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 |
| Dr Tanisha Mali |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA |
7021643689
tanishamali04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. G. D. Pol Foundation College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G243||Spasmodic torticollis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
The Effect of Cervical Proprioceptive Neuromuscular Facilitation
along with Pressure Biofeedback on improving Severity, Range of
Motion and Quality of Life in patients with chronic Cervical
Dystonia- a pre-post interventional study. |
Proprioceptive Neuromuscular Facilitation, Pressure Biofeedback
3 sessions per week for 8 weeks.
Stretch of 20 seconds hold will be given for 3 times for
each muscle group.
Pressure Biofeedback for 10 repetitions with 5
seconds hold. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with chronic (1 year post symptoms)
Cervical Dystonia.
2. Diagnosed with cervical dystonia by a physician.
3. Age group of 20-60 years
4. Both the genders
5. Individuals with Toronto Western Spasmodic
Torticollis Rating Scale score of minimum 35.
6. No history of Botulinum Toxin Injection taken in past 6 months.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with acute Cervical Dystonia.
2. Individuals persisting other cervical deformities
along with cervical dystonia.
3. Participants who have taken Botulinum Toxin
Injection in less than past 6 months span. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Cervical Dystonia: Toronto Western Spasmodic
Torticollis Rating Scale.
2. Severity: Cervical Dystonia Severity Scale (CDSS)
3. Range of Motion: Goniometry
4. Quality of Life: Cervical Dystonia questionnaire 24
(CDQ-24) |
1. baseline data: 1st day of treatment
2. Final data: after 8 weeks of treatment which will be the result data. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
14/10/2025 |
| 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="0"
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
|
Title The Effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on improving Severity, Range of Motion and Quality of Life in patients with chronic Cervical Dystonia – a pre-post interventional study
Overview This study investigates the combined effect of Cervical Proprioceptive Neuromuscular Facilitation (PNF) and Pressure Biofeedback in patients with chronic Cervical Dystonia (CD), a neurological movement disorder characterized by involuntary muscle contractions in the neck, leading to abnormal postures, pain, reduced range of motion (ROM), and diminished quality of life (QoL).
Objectives To assess whether the intervention improves: 1. Severity of cervical dystonia 2. Range of motion of the cervical spine 3. Quality of life of affected individuals
Rationale Current first-line treatments like Botulinum Toxin injections provide symptomatic relief but often leave residual disability. There is limited research on combining PNF with pressure biofeedback as a therapeutic alternative for CD.
Methodology Design: Pre-post interventional study Sample Size: 25 participants Duration: 8 weeks - 3 sessions per week Population: Adults aged 20 to 60 with chronic CD, diagnosed greater than 1 year, TWSTRS score more than 35, no BoNT in last 6 months Tools Used: 1. CD Severity Scale (CDSS) for severity 2. Goniometer for ROM 3. CDQoL-24 Questionnaire for quality of life 4. TWSTRS for baseline inclusion
Intervention PNF: Targeting cervical flexors, extensors, lateral flexors, and rotators using the Contract Relax Antagonist Contract (CRAC) technique Pressure Biofeedback: Sub-occipital positioning of a pressure sensor to facilitate deep neck flexor activation and control
Data Analysis Pre- and post-intervention data will be compared using Paired t-test or Wilcoxon Signed Rank Test depending on data normality. p-value less than 0.05 considered significant. Data analyzed using SPSS v29
Primary Hypothesis Null Hypothesis (H0) There will be no significant effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on severity, range of motion, and quality of life in patients with chronic Cervical Dystonia.
Alternative Hypothesis (H1) There will be a significant effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on severity, range of motion, and quality of life in patients with chronic Cervical Dystonia.
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