| CTRI Number |
CTRI/2024/10/075741 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| 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
|
Effect of Sloped Treadmill Walking on Length of Tendon Connecting Calf Muscle to Heel by Ultrasonography in Healthy Participants |
|
Scientific Title of Study
|
Effect of Inclined Treadmill Walking on Achilles Tendon Length in Asymptomatic Individuals : An Ultrasonographic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aayushi Gupta |
| Designation |
Postgraduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian spinal injuries Centre, Institute of Rehabilitation
sciences, Rehabilitation Department 2nd Floor, Sector C, Vasant kunj,
New Delhi
South West
DELHI
110070
India |
| Phone |
9560984353 |
| Fax |
|
| Email |
guptaaayushi3107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Kataria |
| Designation |
Professor, Principal, ISIC-IRS |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Principal Office, 2nd floor, Indian Spinal Injuries Centre - Institute of
Rehabilitation Sciences, opposite Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9810310670 |
| Fax |
|
| Email |
chitrakataria@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aayushi Gupta |
| Designation |
Postgraduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian spinal injuries Centre, Institute of Rehabilitation
sciences, Rehabilitation Department 2nd Floor, Sector C, Vasant kunj,
New Delhi
South West
DELHI
110070
India |
| Phone |
9560984353 |
| Fax |
|
| Email |
guptaaayushi3107@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New
Delhi. South West DELHI, 110070, India. |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
N/A |
| 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 |
| Aayushi Gupta |
Indian Spinal injuries Centre |
Indian spinal Injuries
Centre, Institute of
Rehabilitation
Sciences, Rehabilitation
Department 2nd Floor,
Sector C, Vasant kunj, New Delhi
South West
DELHI |
9560984353
guptaaayushi3107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic Individuals with Achilles Tendon Tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inclined Treadmill Walking |
Inclined treadmill walking will be given for 10 minutes for 3 sessions over the course of 3 weeks |
| Comparator Agent |
Treadmill Walking on Level Condition |
Treadmill Walking on level condition will be given for 10 minutes for 3 sessions over the course of 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic Individuals, Ankle dorsiflexion range of motion: less than 20°, non-weight bearing |
|
| ExclusionCriteria |
| Details |
History of neurological disorder, History of low back pain and lower extremity injuries/disorder within last 6 months, History of foot and ankle surgery or Achilles tendon rupture, Presence of any lower limb deformity, Person diagnosed with cognitive impairment, Person unable/unwilling to give informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ankle range of motion using universal goniometer
Achilles tendon length using Diagnostic ultrasound |
Day 0 (Baseline, Pre-test) and at 3 weeks (Post-test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/11/2024 |
| 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="7"
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
|
Decreased Achilles
tendon length can limit dorsiflexion range of motion, potentially leading to
issues like midfoot and forefoot pathologies, plantar fasciitis, knee pain, and
altered gait.
Existing
literature shows that Achilles tendon length and ankle dorsiflexion range of
motion improve immediately after inclined treadmill walking, which may help
prevent or alleviate musculoskeletal problems. Diagnostic ultrasound is an
effective imaging technique for evaluating tendons.
However, to the best
of our knowledge, no study has checked the short-term effect of inclined
treadmill walking on Achilles tendon length and ankle dorsiflexion range of
motion.
Patients will be
selected based on inclusion and exclusion criteria. They will be divided into 2
groups with the help of randomization software. One group will do inclined
treadmill walking and the other group will do treadmill walking on level
condition for 10 minutes for 3 sessions for the time period of 3 weeks.
The outcome
measurements will be done by Diagnostic ultrasound for Achilles tendon length
and universal goniometer for ankle dorsiflexion range of motion. Variations in
pre- and post- outcome measures will help us to find out the effect of inclined
treadmill walking on Achilles tendon length.
|