| CTRI Number |
CTRI/2024/11/077479 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Checking balance improvement after using fall prevention methods in patients with decreased bone mass. |
|
Scientific Title of Study
|
Assessment of improvement of balance after implementing fall prevention techniques in patients with osteoporosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laiphrakpam Ishwarlal Singh |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
OPD Room 1, Department of PMR ,IPGMER AND SSKM Hospital,AJC Bose road
Kolkata
WEST BENGAL
700020
India |
| Phone |
9612996643 |
| Fax |
|
| Email |
ganeshlal3737@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amalesh Basak |
| Designation |
Assistant Professor ,Department of PMR |
| Affiliation |
IPGMER AND SSKM |
| Address |
Department of PMR, IPGMER and SSKM , AJC Bose Road
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051924662 |
| Fax |
|
| Email |
amaleshbasakphysiatrist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amalesh Basak |
| Designation |
Assistant Professor ,Department of PMR |
| Affiliation |
IPGMER AND SSKM |
| Address |
Department of PMR, IPGMER and SSKM , AJC Bose Road
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051924662 |
| Fax |
|
| Email |
amaleshbasakphysiatrist@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital , AJC Bose road , Kolkata , West Bengal ,700020 |
|
|
Primary Sponsor
|
| Name |
Dr Laiphrakpam Ishwarlal Singh |
| Address |
OPD Room 1, Department of PMR, IPGMER AND SSKM, AJC Bose Road, Kolkata,700020 |
| 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 Laiphrakpam Ishwarlal Singh |
IPGMER AND SSKM Hospital |
OPD Room 1, Department of PMR ,AJC Bose Road ,700020
Kolkata
WEST BENGAL |
9612996643
ganeshlal3737@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committtee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3 basic exercises and oral medications for osteoporosis . |
3 basic exercises are Static spine exercises,ROM exercises of lower limbs and deep breathing exercises should be done for 30 minutes,3 times per week. Dosage of oral medications Paracetamol 650mg done thrice weekly as analgesics as needed,Calcium -1500 mg/day for 3 months,Vitamin D3 -1000 IU/day for 3 months, Bisphosphanates (T. Risedronate 35mg )once weekly to be continued. |
| Intervention |
Fall Prevention Techniques,
3 basic exercises,
Oral medications for osteoporosis. |
Fall Prevention Techniques which includes Balance training exercises,Strength training exercises and environment modifications are
Instructed by doctor and physiotherapist . Exercises to be done for 30 minutes , 3 times per week including 3 basic exercises :static spine exercise ,ROM exercises of lower limb , deep breathing exercise at home . Dosage of oral medications Paracetamol 650mg as analgesics as needed,Calcium -1500 mg/day for 3 months,Vitamin D3 -1000 IU/day for 3 months, Bisphosphanates (T. Risedronate 35mg )once weekly to be continued. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants must have a primary osteoporosis diagnosis based on recognised diagnostic standards, such as clinical evaluations or measures of bone mineral density (on DEXA, BMD – T score less than or equal to -2.5, WHO classification).
Participants should be physically and mentally capable of taking part in the balancing tests and fall prevention strategies. This could be evaluated via a screening procedure or medical assessment |
|
| ExclusionCriteria |
| Details |
People with serious neurological illnesses that could influence balance.
People who have recently suffered fractures that might make it difficult for them to participate in interventions or assessments.
People with severe comorbidities who would make it difficult for them to take part in the study or comprehend the results.
Cases of secondary osteoporosis.
Participants with any conditions that make using the Balance Analyser or engaging in fall prevention strategies unsafe.
Those who planned to be out of town for more than 4 weeks during study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters which are taken from Balance analyser that will measure and assess the balance improvement in patients are:Sway Index % difference (overall) in bilateral comparison test,Stability index (overall) in postural stability test,Composite score- average in CTSIB test (Clinical Test of Sensory Integration of Balance),Sway Velocity Index (SVI) Composite Score in fall risk test .
|
At baseline, 2 weeks,4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/12/2024 |
| 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="9"
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
Modification(s)
|
Balance deficits significantly contribute to the risk of falls and subsequent fractures, which can lead to severe morbidity, decreased quality of life, and increased healthcare costs. The primary objective of this study is to evaluate the impact of fall prevention techniques specifically balance training and strengthening exercises on balance improvement in patients diagnosed with osteoporosis. The use of a Balance analyser provides a thorough and impartial evaluation of balance management. These analysers offer quantitative information on various characteristics, including sway index, stability index, composite score-average in CTSIB, and postural sway velocity allowing for an accurate assessment of balance status and advancement over time. Precise and extensive information can be gathered regarding balance outcomes by including balance analyser measures in the assessment, resulting in a more thorough and impartial evaluation of the interventional effectiveness.
|