| CTRI Number |
CTRI/2025/01/079708 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| 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
|
Evaluating the impact of pilates training combined with kinesio tape on spinal curvatures and respiratory parameters in geriatric population with degenerative postural hyperkyphosis
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Scientific Title of Study
|
Exploring the impact of pilates training combined with kinesio tape on spinal curvatures and respiratory parameters in geriatric population with degenerative postural hyperkyphosis: A non blinded 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 |
Pooja Kumawat |
| Designation |
MPT |
| Affiliation |
Post graduate student , SGT university |
| Address |
Department of Faculty of Physiotherapy,Shree Guru Gobind Singh Tricentenary University, Chandu budhera
Gurgaon HARYANA 122505 India |
| Phone |
9694811184 |
| Fax |
|
| Email |
pooja.kumawat1212@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanka rishi |
| Designation |
Associate professor |
| Affiliation |
Associate professor, SGT University |
| Address |
Department of faculty of physiotherapy, Shree Guru Gobind Singh Tricentenary University, Chandu budhera
Gurgaon HARYANA 122505 India |
| Phone |
8588878467 |
| Fax |
|
| Email |
priyanka.physio@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Pooja Kumawat |
| Designation |
Student |
| Affiliation |
Post graduate student , SGT university |
| Address |
Department of Faculty of physiotherapy, Shree Guru Gobind Singh Tricentenary University, Chandu Budhera
Gurgaon HARYANA 122505 India |
| Phone |
9694811184 |
| Fax |
|
| Email |
pooja.kumawat1212@gmail.com |
|
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Source of Monetary or Material Support
|
| Faculty of Physiotherapy , SGT University Chandu Budhera Village 122505 |
|
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Primary Sponsor
|
| Name |
Pooja kumawat |
| Address |
Faculty of physiotherapy,Shree Guru Gobind Singh Tricentenary University, Gurugram 122505 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snigdha Tiwari |
SGT Hospital |
Room Number: 13, Department of physiotherapy Gurgaon HARYANA |
9893533630
Snigdha_fphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental ethical committee, faculty of physiotherapy, SGT University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-Pilates training combind+kinesiotape+ conventional physiotherapy exercises |
Participant will perform Pilates Training [Hundred level,
Single leg stretch,
Single leg circle,Single leg stretch,Saw neck
pull,Swimming,Single leg lift Prone Pilates roll-up,Swan exercise,Spine twist,Cat-cow stretch,Hundreds in standing table,One leg kick,Criss-cross,Breast stroke,Spine stretch forward,Child pose,Prone back extension,Double leg kick,
Double leg stretch]Combined with Kinesio Tape [Starting at the anterior portion of the acromioclavicular joint, the tape will be placed across the spinous process at T6, ending at the Paraspinal muscle at T12, bilaterally and symmetrical. (X-shaped)] with conventional physiotherapy exercises[Chest stretching and diaphragmatic breathing, Prone hip extension and Postural awareness Lecture] The treatment protocol of one hour sessions twice a week over a total of 10 sessions will be given in the supervision of the researcher for both the groups. |
| Comparator Agent |
Group B-Conventional Physiotherapy exercise |
Participant will perform
Conventional Physiotherapy exercise Chest stretching and diaphragmatic breathing, Prone hip extension. Postural awareness lecture (Changes due to the aging process and the act of falling down, changes due to aging and its effects on posture physical activity,Quality of life and overall health for the elderly).The treatment protocol of one hour sessions twice a week over a total of 10 sessions will be given in the supervision of the researcher for both the groups. The lectures lasted approximately 30 minutes. |
|
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Above 60 years of age,
2.Patients with degenerative postural hyperkyphosis
3.Subjects must have a spinal condition- kyphosis angle greater or equal to 40° measured at the screening visit
4.Patients ready for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Subjects presented with acute or chronic injury within the previous 3 month.
2.Subjects with any conditioning program within 3 month.
3.History of skin allergy with taping
4.Uncooperative subject.
5.Unwillingness to continue the exercise sessions
6.Any spinal condition like scoliosis, a history of spinal column fracture, spinal tumors and related malignancies, congenital spinal anomalies, cancer, and rheumatoid arthritis, ankylosing spondylitis, vertebral tumors, vertebral fractures
and Presence of any neurological or motor sequelae, cognitive deficits, signs of nerve compression or cauda equina syndrome. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Spinal curvature(Kyphotic angle,Lordotic angle,posture)
Respiratory parameter[Chest expansion (poor respiratory function),Rate of perceived exertion]
|
Day 1 assesment 5th week assesment
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life,
Static balance,
Functional mobility
|
Day 1 assesment 5th week assesment
|
|
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Target Sample Size
|
Total Sample Size="68" Sample Size from India="68"
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)
|
08/02/2025 |
| 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="0" 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
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Brief Summary
|
Kyphosis is the natural curvature of the thoracic spine, characterized by a slight forward curvature due to the shape of vertebral bodies and intervertebral discs. According to the Cobb angle approach, the usual range for younger adults is normally between 20 and 40 degrees of curvature. However, this angle may start to rise above 40 degrees as people get older than their fourth decade, leading to excessive curvature termed as "age-related hyperkyphosis." It could emerge in adolescence. According to estimates, the incidence of this deformity was 15% in children aged 11 to 50, 38% in adults aged 20 to 50, and 20% to 40% in persons aged 60 and above. Women are primarily affected, especially during the menopause. Women’s kyphosis angles grow more quickly after the age of 40, from an average of 43° (ages 55–60) to 52° (ages 76–80). Poor postural habits and slouching can be the cause of this deformity. Additional causes of age-related hyperkyphosis include vertebral body wedging, chronically bad posture, decreased spinal extension mobility, intervertebral disk dehydration, and weakened back extensor muscles. Physical deformity, low stature, limited spinal mobility, back pain, and probably diminished respiratory capacity are all consequences of hyperkyphosis that ultimately cause people to have a negative body image. Pilates, a low-impact training regimen that emphasizes postural alignment, core strength, and flexibility, has demonstrated potential in enhancing respiratory and spinal biomechanics. Furthermore, by aiding postural correction, improving respiratory mechanics, and offering proprioceptive feedback, Kinesio taping—which is frequently used in therapeutic settings—may be a useful adjunct to Pilates. It has been widely utilized to improve tissue alignment, activate muscular function, and stimulate the somatosensory system in order to relieve pain. For geriatric population as a whole to improve excessive thoracic curvature (>40°), or hyperkyphosis, which is a common spinal condition that worsens with age, especially in postmenopausal women , Pilates is a low-impact exercise technique that can be used to increase flexibility and respiratory efficiency while also improving postural alignment, spinal biomechanics, and core strength. Additionally, by aiding postural adjustment, reducing discomfort, and offering proprioceptive feedback, Kinesio taping can be used in conjunction with Pilates. When combined, these therapies can lessen the negative effects of hyperkyphosis, strengthen body mechanics, and improve the general well-being of those who are impacted. Null Hypothesis
H01 – Pilates Training combined with kinesio tape will not produce any significant difference on Spinal Curvatures (Kyphotic angle, Lordotic angle and Posture) and Respiratory Parameters (Poor respiratory function, Rate of perceived exertion) and Functional mobility, Static balance, Quality of life in Geriatric Population with degenerative Postural Hyperkyphosis.
Alternate Hypothesis
H1 - Pilates training combined with kinesio tape will produce any significant difference on Spinal Curvatures (Kyphotic angle, Lordotic angle and Posture) and Respiratory Parameters (Poor respiratory function, Rate of perceived exertion) and Functional mobility, Static balance, Quality of life in Geriatric Population with degenerative Postural Hyperkyphosis. |