| CTRI Number |
CTRI/2018/01/011538 [Registered on: 24/01/2018] Trial Registered Prospectively |
| Last Modified On: |
22/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of task specific training and resistance training to improve balance and mobility among diabetic peripheral neuropathy
Subjects– a randomized clinical trial |
|
Scientific Title of Study
|
Comparison of task specific training and resistance training to improve balance and mobility among diabetic peripheral neuropathy
Subjects– a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kalluri Anusha |
| Designation |
MPT |
| Affiliation |
Manipal Acadamy Of Higher Education |
| Address |
Department of physiotherapy,
kasturba medical college,
mangaluru.
light house hill road, hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7382411841 |
| Fax |
|
| Email |
anu.kalluri17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Associate Professor |
| Affiliation |
Manipal Acadamy Of Higher Education |
| Address |
Department of physiotherapy,
kasturba medical college,
mangaluru.
light house hill road, hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9980189597 |
| Fax |
|
| Email |
vijaykmcmangalore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kalluri Anusha |
| Designation |
MPT |
| Affiliation |
Manipal Acadamy Of Higher Education |
| Address |
Department of physiotherapy,
kasturba medical college,
mangaluru.
light house hill road, hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7382411841 |
| Fax |
|
| Email |
anu.kalluri17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Acaedmy of Higher Education |
| Address |
light house, hill road,mangalore,575001 |
| 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 |
| Kalluri Anusha |
KMC mangalore |
Department of Physiotherapy, 5th floor,KMC Hospital,Jyothi circle, Mangalore
Dakshina Kannada
KARNATAKA |
7382411841
anu.kalluri17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Karturba Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Peripheral Neuropathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
resistance training |
resistance training for 60 minutes of training protocol in which 50 minutes is for resistance exercises using elastic band to both lower extremities,4 times per week for 3 weeks |
| Intervention |
task specific training |
task specific training for 60 minutes in which 50 minutes will be for task specific training with motor learning programme in standing, walking, stair climbing and 10 minutes is for warm up and cool down,4 times per week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Diabetic patients for more than 5 years with age group ≥ 40 of both the genders.
2.Michigan neuropathy screening instrument score(examination version≥2.5)
3.Timed up and go test score ≥ 13.5 sec |
|
| ExclusionCriteria |
| Details |
1.Subjects who are unable to walk independently 2.Musculoskeletal conditions like osteoporosis 3.Peripheral vascular diseases
4.Other neurological disorders interfering balance and mobility.
5.Unstable cardiovascular conditions
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mini bestest,timed up and go,quality of life in indian diabetes questionnaire, fall efficacy scale |
pre intervention and post intervention (3weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| vibration perception threshold, dynamometer |
pre intervention and post intervention (3weeks) |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subjects who are screened with diabetic peripheral neuropathy are referred to the Department Of Physiotherapy by the clinician. informed consent will be taken from willing subjects. Eligible subjects alter screening of exclusion and inclusion criteria will be explained the purpose of the study and demographic data also will be collected.The screening is done by using mitchigen neuropathy screening scale for sensory impairement, timed up and go test for balance impairement. The eligible subjects will be allocated to two groups by randomisation .pre intervention outcomes will be taken from both the groups.
group A will recieve task specific training and group B will recieve resistance training . In Group A, task specific training is given in standing, walking and stair climbing and the progression is done by incorporating biomechanical, physical demands, sensory integration, cognitive demands, motor learning principles. In group B the resistance training is given by elastic band and progression is done by change in the colour of the band. Training is given for about 60 minutes, 4times a week for about 3 weeks. Post intervention outcome measures will be collected by an independent blinded assessor.
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