| CTRI Number |
CTRI/2016/06/007051 [Registered on: 29/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/10/2016 |
| 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
|
Effect of a novel technique to correct knee hyperextension in subjects with stroke |
|
Scientific Title of Study
|
Effectiveness of prowling with proprioceptive training on knee hyperextension in stroke subjects- A randomised controlled trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushboo Dalal |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy, KMC hospital,
Jyoti circle
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9028141639 |
| Fax |
|
| Email |
khushboo.k.dalal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abraham M Joshua |
| Designation |
Senior associate professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy, KMC hospital ,
Jyoti circle
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Khushboo Dalal |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy, KMC hospital,
Jyoti circle
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9028141639 |
| Fax |
|
| Email |
khushboo.k.dalal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal University |
| 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 |
| Dr khushboo k dalal |
KMC mangalore |
Department of Physiotherapy, 5th floor
KMC hospital,
Jyoti circle
Mangalore
Dakshina Kannada
KARNATAKA |
9028141639
-
khushboo.k.dalal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
acute stroke subjects, walking with knee hyperextension and Brunnstorm recovery stage 3 and above, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional therapy |
routinely prescribed exercises for stroke 45-60 minutess per day,once daily, for 6 days |
| Intervention |
prowling and proprioception training |
prowl walking
proprioceptive exercises 60-80 minutes per day, once daily, for 6 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
acute stroke
hemiplegic participants walking with knee hyperextension of knee
MMSE more than or equal to 24 |
|
| ExclusionCriteria |
| Details |
any musculoskeletal disease affecting knee joint |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| videographic analysis |
Pre intervention and post intervention (6 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| wisconsin gait index |
nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diagnosed stroke subjects, referred by neurologists to the Department of Physiotherapy will be approached. Informed consent will be taken from willing subjects. Eligible subjects after screening of exclusion n inclusion criteria will be explained the purpose of the study and Demographic data also will be collected. The eligible subjects will be allocated to two groups by randomizationsation i.e group A (experimental) and group B (control). The baseline data will be collected by video-graphy and WGS. A camera mounted on tripod stand with spirit level will be kept at 4 meters perpendicular distance from the midpoint of walkway. Plumb line will ensure that the camera is on specified point. And height of the camera will be corresponding to the level of greater trochanter. Ductapes will be used to mark the specified distance. The subject will be made to walk 5m distance and this will be video recorded. Naked eye video analysis will be done by kinovea movement analysis software and following things will be noted: 1. The degree of hyperextension of knee 2. The degree of ankle dorsiflexion 3. The number of times knee goes into hyperextension 4. The total time taken to complete this distance. After videography analysis Wiscosin gait scale will be assessed. Both the groups would be given routine stroke exercises. Group A will be given following exercises in addition for approximate 20mins: 1. Walking in partial squat position or prowling. 2. Partial squats 3. Single limb stance. 4. Single limb partial squat stance on stable surface (affected limb weight bearing) with or without support 5. Single limb partial squat standing on a piece of foam (affected limb weight bearing) with or without support. |