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CTRI Number  CTRI/2023/04/051534 [Registered on: 12/04/2023] Trial Registered Prospectively
Last Modified On: 01/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the balance and strength training versus joint mobilisation(MWM) among the young adults with chronic ankle instability 
Scientific Title of Study   A study to compare the efficacy of balance and strength training versus joint mobilisation(MWM) on improving ankle instability among the young adults with chronic ankle instability: a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suhana V 
Designation  Masters of Physiotherapy in Musculoskeletal Sciences 
Affiliation  Narayana Hrudayalaya Institute of Physiotherapy 
Address  Narayana Hrudayalaya Foundations, #258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9741756100  
Fax    
Email  suhana982@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Smruti Swagatika Dash 
Designation  Professor 
Affiliation  Narayana Hrudayalaya Institute of Physiotherapy 
Address  Narayana Hrudayalaya Foundations, #258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9448552026  
Fax    
Email  smruti.dash@hrudayalayafoundation.org  
 
Details of Contact Person
Public Query  
Name  Suhana V 
Designation  Masters of Physiotherapy in Musculoskeletal Sciences 
Affiliation  Narayana Hrudayalaya Institute of Physiotherapy 
Address  Narayana Hrudayalaya Foundations, #258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9741756100  
Fax    
Email  suhana982@gmail.com  
 
Source of Monetary or Material Support  
Narayana Hrudayalaya Health City, #258/A, Bommasandra Industrial Area, Bangalore-560099 
 
Primary Sponsor  
Name  Suhana V 
Address  Narayana Hrudayalaya Foundations, #258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore 
Type of Sponsor  Other [Physiotherapy Institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Suhana V  Physiotherapy OPD  Narayana Hrudayalaya Health City, #258/A, Bommasandra Industrial Area, Bangalore- 560099
Bangalore
KARNATAKA 		 9741756100

suhana982@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M253||Other instability of joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Joint Mobilisation(Movement with mobilisation)  Participants will be given 30 minutes of exercises. 3 days a week for 4 weeks. Group B: This group will consist of 38 subjects who will be provided with joint mobilization(MWM) in weight bearing position along with the conventional therapy. The MWM will be administered with the participant relaxed, standing on a couch. A non-elastic belt will be passed around the distal leg of the participant and the physical therapist’s pelvis who will be positioned in front of the participant’s leg. Then the therapist will apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards while the talus and forefoot will be fixed with the space between the thumb and the second right hand finger. The other hand will be positioned anteriorly over the proximal tibia to direct the knee over the line of the 2nd and 3rd toes. Then, the participant will be instructed to perform a slow dorsiflexion movement. Subjects will undergo MWM in weight bearing position for 10 successful repetitions.  
Comparator Agent  Not applicable  Not applicable 
Intervention  Strength and Balance training   Participants will be given 30 minutes of exercises. 3 days a week for 4 weeks. Group A: This group will consist of 38 subjects and they will undergo balance and strength training along with conventional intervention. It will be consists of resistance exercises with resistance band and wobble board exercises. During each session, patients will complete resistance training using a resistance band in 4 directions of ankle motion (plantar flexion, dorsiflexion, inversion, eversion) of 3 sets each consisting of 10 repetitions. The resistance band will be doubled and securely attach to the base of a treatment table. Each week, the patient will be progressed to the next resistance-band colour level (from red to green, blue, and black). They will perform a 1-legged stance using their test limb on the wobble board while completing clockwise and counter-clockwise circles. Five 40-second trials will be completed with 1-minute rest intervals between trials. Subjects will perform 10 successful repetitions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) A history of atleast 1 significant ankle sprain on the same side
2) Age group between 18 to 25 years
3) Asymmetry larger than 2cm on the weight bearing lunge test(WBLT) for ankle dorsiflexion
4) Self reported unilateral Chronic Ankle Instability
5) A history of atleast 2 episodes of giving way of the injured ankle joint in the 6 months prior to study enrollment
6) The participants must not have sustained an ankle sprain within 3 months of the start of the study
7) Participants who had a score of Cumberland Ankle Instability Tool(CAIT) of less than 24 points
8) Participants not receiving any alternative treatment during the study  
 
ExclusionCriteria 
Details  1) The participants with history of lower extremity injury/surgery, any history of head
injury, and any vestibular or balance disorders
2) A history of a fracture in either limb of the lower extremity requiring realignment
3) Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (i.e, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
4) A history of bilateral ankle injury
5) Participants were excluded from the study if they missed more than two therapeutic sessions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Dorsiflexion Range of Motion(DFROM)- (Active Dorsiflexion ROM), Dynamic Balance(Y balance test), Cumberland Ankle Instability Tool(CAIT)(CAIT score)  Baseline- 0 week
Post intervention- 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Pain(Visual Analog Scale), Proprioception(Degree of joint position sense), Static Balance(One leg stance test)  Baseline- 0 week
Post intervention- 4th week 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   12/04/2023 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Purpose :- To determine the efficacy of balance and strength training with conventional physiotherapy versus joint mobilisation(MWM) with conventional physiotherapy on improving ankle instability among the young adults with chronic ankle instability.
Hypothesis:
Null Hypothesis [H0]:
There will be no significant effects of balance and strength training with conventional physiotherapy on improving pain, range of motion, proprioception, balance, functional performance in the young adults with chronic ankle instability.
There will be no significant effects of joint mobilization (MWM) with conventional physiotherapy on improving pain, range of motion, proprioception, balance, functional performance in the young adults with chronic ankle instability.
There will be no significant differences in balance and strength training with conventional physiotherapy compared to joint mobilisation (MWM) with conventional physiotherapy on improving pain, range of motion, proprioception, balance, functional performance in the young adults with chronic ankle instability.
Alternate Hypothesis [H1]:
There will be significant effects of balance and strength training with conventional physiotherapy on improving pain, range of motion, proprioception, balance, functional performance in the young adults with chronic ankle instability.
There will be significant effects of joint mobilisation(MWM) with conventional physiotherapy on improving pain, range of motion, proprioception, balance, functional performance in the young adults with chronic ankle instability.
There will be significant differences in balance and strength training with conventional physiotherapy compared to joint mobilisation(MWM) with conventional physiotherapy on improving pain, range of motion, proprioception, balance, functional performance in the young adults with chronic ankle instability.
 
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