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CTRI Number  CTRI/2024/07/070345 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
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   Comparing Therapeutic Interventions of ribcage mobilisation vs kinesio-taping for Thoracic Spine Alignment in Parkinsons Disease  
Scientific Title of Study   Short-term Effect of Rib Cage Mobilisation versus Kinesio-taping on Thoracic Spine Alignment in Patients with Parkinsons Disease  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palak Maloo 
Designation  PG student 
Affiliation  Maeers physiotherapy college 
Address  Maeers physiotherapy college near railway station 2nd floor Neurophysiotherapy department Cabin no A-230 talegoan dabhade maval pune

Pune
MAHARASHTRA
410507
India 
Phone  8805855898  
Fax    
Email  palakmaloo1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sayli Paldhikar 
Designation  Professor 
Affiliation  Maeers physiotherapy college 
Address  Maeers physiotherapy college near railway station Cabin no A-230 2nd floor neurophysiotherapy department talegoan dabhade maval pune

Pune
MAHARASHTRA
410507
India 
Phone  8805174616  
Fax    
Email  saylithuse@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sayli Paldhikar 
Designation  Professor 
Affiliation  Maeers physiotherapy college 
Address  Maeers physiotherapy college near railway station Cabin No A-230 2nd floor neurophysiotherapy department talegoan dabhade maval pune

Pune
MAHARASHTRA
410507
India 
Phone  8805174616  
Fax    
Email  saylithuse@gmail.com  
 
Source of Monetary or Material Support  
Maeers Physiotherapy college Talegaon Dabhade Maval pune 410507 
 
Primary Sponsor  
Name  Maeers physiotherapy college talegoan dabhade 
Address  Maeers physiotherapy college near railway station cabin no A-230 2nd floor neurophysiotherapy department talegoan dabhade maval pune 
Type of Sponsor  Private medical college 
 
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 
Dr Sayli Paldhikar  Maeers physiotherapy college talegoan dabhade  Maeers Physiothearpy college near railway station Cabin no A-230 2nd floor neurophysiotherapy department talegaon dabhade Pune 410507
Pune
MAHARASHTRA 
8805174616

saylithuse@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maeers college of physiotherapy ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kinesio-taping on thoracic spine  The reference points acromioclavicular joint and T7 will be determined by palpation, and marked. Taping will be applied starting from the acromioclavicular joint without stretching and will go on with maximum stretching to the level of the thoracic 7th vertebra. Taping will be terminated without stretching after 7 thoracic vertebrae levels. Two I-shaped elastic tapes will be applied diagonally from the anterior of the right and left acromion towards the back. The taping will be done on 1st and 4th day.  
Comparator Agent  Rib cage mobilisation  The rib cage joint mobilization procedure will consist of applying a posteroanterior unilateral costovertebral pressure on both side and a posteroanterior central vertebral pressure. An oscillatory movement will be performed at the joint by the thumbs or hands Grade III joint mobilization will be performed. Intervention will be performed as three sets of 30 repetitions for a minute, with 1-minute intermissions between the sets. Whole intervention will be repeated for 3 alternate days for a week.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Parkinson’s patients on medication.
2 Participants with forward trunk flexion (stooped posture) at thoracic level checked by plumb line.
 
 
ExclusionCriteria 
Details  1 Participants with other neurological conditions.
2 Participants with spinal deformity (extreme kyphosis, scoliosis) and who have undergone any surgery for upper limb and spine in past 6 months.
3 Participants allergic to Kinesio-tape (checked by patch test).
4 Participants who cannot lie prone for more than 15 minutes.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Thoracic mobility scale to assess the degree of trunk flexion  Pre 0 week and Post intervention of 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Clinometer mobile app to assess the degree of trunk flexion  Pre 0 week & Post intervention of 1 week 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   31/07/2024 
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="11"
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  
•Parkinson’s disease (PD) is the most common neurodegenerative movement disorder, which is characterized by four cardinal features: rest tremor, rigidity, bradykinesia and postural instability. 
•Although the pathology of postural instability is unknown, several hypotheses exist.
•According to Karen M Doherty: In patients with Parkinson’s, the reduced spinal movements cause an effort to maintain the body gravity line within the limits of stability and are usually compensated by increased trunk flexion. 
•According to Zhang T: The stooped posture in Parkinson’s  may be because of  tonic hyperactivity of the flexors due to abnormal drive from the basal ganglia.
•According to Gross AK: stooped posture in Parkinson’s  may be compensatory strategy to facilitate forward motion of the Center of Mass for step initiation. 
•Dietz et al. further noted that Parkinson’s patient stoop for compensation to backward falls and  its not a cause of, primary postural deficits in PD. 
•The clinical assessment of stopped posture is very important for evaluating the functional and physical consequences of the disease and the risk factors for its progression.
•Therefore, therapeutic approaches including active posture correction and proprioceptive stimulation are thought to be effective on axial symptoms.
•Mobilization is a multiple, controlled, bidirectional, small to large amplitude, rhythmic oscillation given within physiological range.
• Kinesio taping aims to activate the proprioceptive system by increasing sensory stimuli with cutaneous mechanoreceptors and also helps to improve anticipatory postural
adjustments and activate trunk muscles and joints without restricting body movements.
•Studies have shown that kinesio taping improves postural control not only by increasing proprioceptive sensation, but also by determining the correct joint position for a
comfortable and non-burdening posture. 
•In recent years, it has been utilized in musculoskeletal and neurological diseases with the aim of increasing or inhibiting muscle activity, providing joint repositioning,
preventing injuries and improving proprioception. 
•Stooped posture in Parkinson’s patients have its negative effect on balance, which cause falls, resulting in extremity and spinal-compression fractures, and also
detoriate  their quality of life.
•Rib cage mobilization can contribute to improve posture by addressing restrictions and imbalances in the thoracic spine and surrounding musculature.
•It will also help patients with improved mobility of spine, improved breathing and relaxation.
•It has been stated in recent studies that elastic taping can be used for postural correction and can be an effective form of cutaneous proprioceptive biofeedback.
•Moreover, previous studies have developed several invasive treatments for stooped posture, such as deep brain stimulation and botulinum toxin injected into the
primary-culprit muscles for the condition. However, the effect of these treatments on stooped posture has remained controversial over the years.
•Therefore, non-invasive treatment for stooped posture in Parkinson’s patients needs to be established.

•Samples will be randomly and equally divided into 2 groups.

      Group A :- will receive rib cage mobilisation intervention

      Group B :- will receive kinesio-taping intervention

•All the participants will be assessed pre and post treatment after 1 week using Smart phone application ( Clinometer) and trunk mobility scale.
 
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