| CTRI Number |
CTRI/2024/12/078268 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Neuromuscular electrical stimulation in post-concussion athletes |
|
Scientific Title of Study
|
Effect of vestibular exercise program with neuromuscular electrical stimulation on balance and gait recovery in post concussion combat sports athletes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K K SHRAVAN |
| Designation |
PG SCHOLAR |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09540083933 |
| Fax |
|
| Email |
shravankk004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University Noida Sec 125 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
K K SHRAVAN |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| 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 Jasobanta Sethi |
Amity Institute of Health Allied Science |
Department of Physiotherapy Amity Institute of Health And Allied Science Amity University F1 LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH |
09988600462
jsethi@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy,Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S060||Concussion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NMES + Vestibular Exercise Group (Experimental
Group) |
Neuromuscular
electrical stimulation (NMES) enhances muscle activation and
neuromuscular re-education. NMES Therapy:
a) Quadriceps Stimulation: To improve stability during stance and
gait performance.
b) Tibialis Anterior and Gastrocnemius Stimulation: To assist with
ankle dorsiflexion and plantarflexion during gait.
c) NMES will be applied for 20 minutes per session with a Pulse duration of 200 microseconds having a Frequency of 50pps and RISE time of 2.0 seconds, ON Time of 5.0 seconds,FALL Time of 2.0seconds & OFF Time of 5.0 seconds ,while
participants perform functional movements such as standing and
stepping. Vestibular Exercises:
a) Participants will undergo the same vestibular rehabilitation
exercises as Group 1, focusing on gaze stabilization, balance,
and gait training. NMES will be given at the frequency of 50 pps and total duration of 4 weeks
|
| Comparator Agent |
Placebo NMES + Vestibular Exercise Group
(Placebo Control group): |
Placebo NMES:
a) The NMES device will be applied to the lower limb
muscle groups, but no electrical stimulation will be
provided. This is to simulate the therapy without
delivering actual stimulation.
Vestibular Exercises:
a) Gaze Stabilization: Exercises that challenge visual focus
while moving the head
b) Balance Training: Using balance boards and foam
surfaces to challenge the vestibular system for improved
postural control.
c) Gait Training: Training on uneven surfaces and
directional changes to improve balance and gait during
dynamic movements. This will be given for duration of 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Athletes aged 18-35 years.
2. Diagnosed with post-concussion syndrome lasting more than 2 weeks.
3. Exhibiting balance and gait disturbances confirmed by clinical assessment.
4. Cleared for participation in exercise therapy by a healthcare professional. |
|
| ExclusionCriteria |
| Details |
1. Athletes with pre-existing vestibular disorders unrelated
to concussion.
2. Athletes with contraindications for NMES (e.g.,
pacemaker, skin conditions).
3. Concurrent orthopedic injuries affecting lower limbs.
4. History of neurological conditions other than concussion
(e.g., stroke, multiple sclerosis)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance,Gait |
Baseline, Post Fourth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/12/2024 |
| 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="0"
Months="3"
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
|
Aims & Objectives – • Aim: I. To evaluate the effectiveness of a vestibular exercise program and neuromuscular electrical stimulation on balance and gait recovery in combat sports athletes with post-concussion. II. To evaluate the effectiveness of neuromuscular electrical stimulation combined with vestibular exercises versus placebo neuromuscular electrical stimulation combined with vestibular exercises on balance and gait recovery in post-concussion combat sports athletes. • Objectives: I. To evaluate the effectiveness of placebo NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post concussion. II. To evaluate the effectiveness of NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post-concussion Hypothesis – • Null Hypothesis (H₀): - H01: There will be no significant effect in balance and gait recovery between athletes receiving a placebo NMES and vestibular exercises in post-concussion combat sports athletes.
- H02: There will be no significant effect in balance and gait recovery between athletes receiving NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post-concussion
• Alternative Hypothesis (Hâ‚): - H11: There will be a significant effect in balance and gait recovery between athletes receiving a placebo NMES and vestibular exercises in post-concussion combat sports athletes.
- H12: There will be a significant effect in balance and gait recovery between athletes receiving NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post-concussion
|