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CTRI Number  CTRI/2025/04/084014 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
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   INDOOR SLACKLINING EXERCISES BENEFICIAL ON PAIN RELIEF,DAILY ACTIVITY AND BALANCE AMONG PATIENTS WITH GRADE 1 OSTEOARTHRITIS OF KNEE-A RANDOMIZED CONTROLLED TRIAL 
Scientific Title of Study   EFFECT OF INDOOR SLACKLINING EXERCISES ON PAIN,FUNCTIONAL PERFORMANCE AND BALANCE AMONG PATIENTS WITH GRADE 1 OSTEOARTHRITIS OF KNEE-A RANDOMIZED CONTROLLED 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  Snehal Patil 
Designation  MPT student 
Affiliation  Dr.Ulhas Patil College Of Physiotherapy, Jalgaon 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, physiotherapy OPD, Taluka and District Jalgaon, Maharashtra

Jalgaon
MAHARASHTRA
425001
India 
Phone  7447799048  
Fax    
Email  patilsnehal1502@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaywant Nagulkar 
Designation  Professor & Principal 
Affiliation  Dr.Ulhas Patil College Of Physiotherapy, Jalgaon 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, physiotherapy OPD ,Taluka and District Jalgaon, Maharashtra

Jalgaon
MAHARASHTRA
425001
India 
Phone  9822735329  
Fax    
Email  j4jaywant1981@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradnya Mahajan 
Designation  Assistant Professor 
Affiliation  Dr.Ulhas Patil College Of Physiotherapy, Jalgaon 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, Physiotherapy OPD, Taluka and District Jalgaon, Maharashtra

Jalgaon
MAHARASHTRA
425001
India 
Phone  9284034348  
Fax    
Email  ppradz1816@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ulhas Patil College Of Physiotherapy, Jalgaon NH 06, Gat No. 57 1, Khirdi Shivar, Taluka and District Jalgaon, Maharashtra 425001 India 
 
Primary Sponsor  
Name  Snehal Patil 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, Taluka and District Jalgaon, Maharashtra 
Type of Sponsor  Other [Self] 
 
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 
DrSnehal Patil  Dr. Ulhas Patil College Of Physiotherapy  OPD No 207, Physiotherapy OPD, Taluka and District Jalgaon, Maharashtra
Jalgaon
MAHARASHTRA 		 7447799048

patilsnehal1502@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
intitutional Ethics committee of Dr. Ulhas Patil College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indoor Slacklining Exercises  10 repetitions for each activity, rest interval of 5 mins; 1 session/day for 3 days/ week upto 4 weeks 
Comparator Agent  Standard routine physiotherapy treatment  (1 session/day with rest interval of 1 min) 3times/week alternate days for 4 weeks 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age 45 to 55 years
2. Kellgren Lawrence scale grade 1 osteoarthritis radiograph
3. Knee pain history and NPRS Score [3 to 6]
4. WOMAC Score ranging from 20 to 40 signifying mild to moderate disability.
5. Physically active patients with no balance issues.
6. Normal and overweight body mass index [According to WHO 18.5 to 29.9 kg/m2 ]
 
 
ExclusionCriteria 
Details  1. Recent Knee surgeries and soft tissue injuries
2. Any other recent orthopaedic injury of lower limb
3. Patients who received Intra articular injections
4. Knee deformity [FFD,Genu Valgus and Varus]
5. Vertigo
6. Acrophobia
7. Congenital deformities of lower limb
8. Obese individuals
9. Any Neurological diseases affecting lower limb
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale [NPRS]  pre and post study [after 4 weeks of intervention] 
 
Secondary Outcome  
Outcome  TimePoints 
Y Balance Test  pre and post study [after 4 weeks of intervention] 
Western Ontario and MacMaster Universities Osteoarthritis Index [ WOMAC Scale]  pre and post study [after 4 weeks of intervention] 
 
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)   15/04/2025 
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  

Aim : To study the effect of indoor slacklining exercises on pain, functional performance and balance in grade 1 osteoarthritis knee patients.

 

Objectives are:

1.     To find out the effect of indoor slacklining exercises on pain using Numerical pain rating scale [NPRS]

2.     To find out effect of indoor slacklining exercises on functional performance using Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC]

To find out effect of indoor slacklining exercises on balance using Y Balance test.

 

ยง  Procedure:

1.     Ethical clearance will be obtained from the institutional ethical committee.

2.     The purpose and procedure of the study will be explained to participant.

3.     A written informed consent will be obtained.

4.     Selected participant will be evaluated for the presence of knee pain by following assessment and procedure.

5.     Subjects will be included with diagnosed with grade 1 osteoarthritis knee based on Xray and clinical examinations.

6.     Subjects will be screened according to inclusion & exclusion criteria.

7.     The subjects will be allocated to experimental and control group respectively by other person, selected patients will be randomly allocated into 2 groups experimental and control group.

8.     Physiotherapist and patients will be blinded to group allocation. Allocation concealment will be done using envelop method.

9.     The subjects random allocation will be done by randomized number sequence generator software and respectively subjects will be randomized in experimental and control group.

10.  The pretest outcome measures will be recorded.

11.  And the treatments will proceed till 4 weeks.

12.  After 4 weeks the outcome measures will be assessed and the data will be interpretated by statistical analysis tests.

13.  The result data will be represented in tabular formats.

14.  CONSORT guidelines will be followed in study.

                  Intervention Protocol

 

EXPERIMENTAL GROUP โ€“ INDOOR SLACKLINING EXERCISES

Patients will follow protocol of

1.    Warm up- 5 min of warm up protocol comprising of ankle toe movements, hip-knee flexion, heel raises, trunk flexion-extension-rotations,hamstring stretch,TA stretch,Quadriceps stretch.[9]

2.    Slacklining exercises- Step up for 10 repetitions

                         Step down for 10 repetitions

                         Single leg stand โ€” dominant for 10 repetitions

                               Single leg stand โ€” nondominant for 10 repetitions

                               Walk forward (2 steps) for 10 repetitions

                               Walk back (2 steps) for 10 repetitions

                               Tandem stance dominant back for 10 repetitions

                               Tandem stance dominant forward for 10 repetitions

 

Slackline is at standard height house-step of 250 mm [25cm] is height of slackline along with mat down for protective measures anchored at 3 m of length with 10 repetitions of activities 3 alternate days a week for 4 weeks. Each of the steps involves single-leg standing. Initially, the dominant or unaffected extremity is weight-bearing, which is followed by single-leg support on the nondominant extremity. This is initiated by walking forward, then walking backward. The activity is then progressed to stationary balancing in the Tandem position, which is alternately performed with the dominant and nondominant extremities in the forward versus behind positions.[1,2]

 

DOSAGE: 10 repetitions for each activity, rest interval of 5 mins; 1 session/day for 3 days/ week upto 4 weeks

 

 

CONTROL GROUP:

Participants will be receiving routine physiotherapy. The exercise program comprises a combination of closed kinetic chain and open kinetic chain exercises, including straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, VMO strengthening and semi-squat. In addition, all participants received ultrasound therapy (1.5 watts/cm2 for 7 min in continuous mode) at the knee joint prior to exercise. These all exercises will be for 10 repetitions 2 sets 3 times a week for 4 weeks.[10]

Dosage:- (1 session/day with rest interval of 1 min) 3times/week alternate days for 4 weeks

After 4 weeks post intervention the outcome measures will be assessed again for NPRS, WOMAC, Y balance test 
 
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