| CTRI Number |
CTRI/2025/07/090011 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
How Foot and Ankle Therapy Affects Balance in Older Adults |
|
Scientific Title of Study
|
EFFECT OF ANKLE AND FOOT MOBILIZATION ON STATIC BALANCE IN OLDER ADULTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Nagpal |
| Designation |
PG student |
| Affiliation |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala |
| Address |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital Ambala HARYANA 133207 India |
| Phone |
9817030017 |
| Fax |
|
| Email |
aditingpl2731@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor MMDU |
| Affiliation |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala |
| Address |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital Ambala HARYANA 133207 India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor MMDU |
| Affiliation |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala |
| Address |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital
HARYANA 133207 India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aditi Nagpal |
| Address |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala pincode 133207, haryana , india |
| Type of Sponsor |
Private medical college |
|
|
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 Aditi Nagpal |
mm super speciality hospital mullana ambala haryana india |
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala
ss opd 1st floor room no 112 super speciality hospital Ambala HARYANA |
09817030017
aditingpl2731@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE Communication of decision of the Ethics committee IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
older adults with no lower limb injury |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ankle and foot grade 3 maitland mobilization |
Grade III Maitland accessory mobilization, 3 sets of 30 repetitions with 60 sec intervals bilaterally will be performed. single sesion only |
| Comparator Agent |
neuromuscular training |
trampoline propioception training tandem stance |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 60 to 75 years
2 Both males and females
|
|
| ExclusionCriteria |
| Details |
Chronic Ankle instability
History of ankle and foot fracture in the last six month
Previous history of stroke in the last six month
Any other neurological disorder
Previous history of any eye surgery in the last six months
Vestibular disorder
Arthritis of the lower extremity
Any other musculoskeletal disorder of lower limb
Metabolic disorder like- Diabetes mellitus, High blood pressure
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
4 stage balance test
|
4 stage balance test
baseline and immediate after session
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BESS Balance Error Scoring System |
baseline & immediate after intervention |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2025 |
| 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
|
overall balance begins to decline in a progressive way from midlife starting at about age fifty sensory motor and integrative system participate and interact in postural control any deterioration in these systems or in the underlying mechanism of balance will effect this complex ability falls are the major threats to older adults quality of life often causes decline in self care ability and participation in physical and social activities fear of falling develops in twenty to thirty nine who fall can lead to further limiting activity independent of injury the foot and ankle are of especial importance since they constitute the base of support of the body and transmit the loads to the ground However common age related alterations such as loss of strength and limited range of motion due to loss of quality of the musculature of the joint complex has a negative impact on balance by altering gait patterns and increasing the risk of fall among other consequences in the case of the ankle arthrokinematics manual therapy based on the joint mobilization techniques has proven to be useful tool to recover the normal range of movement and balance still there are lack of evidence which says about static balance to determine the efficacy of ankle and foot mobilization on static balance in older adults Single blinded Two group pre and post experimental design Patients will be recruited based on inclusion and exclusion criteria There will be pre and post balance assessment of each individual four stage balance test and BESS will be used to assess the static balance of an individual Grade Three Maitland mobilization of ankle and foot for will be given bilaterally The collected data will be analyzed by using SPSS twenty version Normality analysis will be done with the help of Shapiro Wilk Kolmogorov Smirnov test Descriptive statistics will be expressed as either Mean Standard Deviation or Median IQR |