| CTRI Number |
CTRI/2017/05/008565 [Registered on: 16/05/2017] Trial Registered Prospectively |
| Last Modified On: |
19/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Influence of weights tied at ankle on balance and leg muscle activity in persons with hemiplegia |
|
Scientific Title of Study
|
Influence of ankle loading on standing postural control and lower limb muscle activation in persons with stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Lalakia |
| Designation |
Student (MPT 1st year) |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9036137119 |
| Fax |
|
| Email |
priyanka.lalakia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Senthil Kumaran D |
| Designation |
Associate professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Selvam Ramachandran |
| Designation |
Associate professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686738297 |
| Fax |
|
| Email |
selvam.ram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Priyanka Lalakia,
PG student,
Department of Physiotherapy,
SOAHS, Manipal University,
Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal |
| 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 |
| Priyanka Lalakia |
Kasturba hospital |
N1, Near ALC, Department of Physiotherapy, Kasturba Hospital, Manipal University, Manipal-576104
Udupi
KARNATAKA |
9036137119
priyanka.lalakia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC KHIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Sub-acute and Chronic Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ankle loading |
Varying ankle loads will be applied on paretic ankle stroke patients and postural sway and weight symmetry using posturography and muscle activation using wireless EMG will be calculated |
| Comparator Agent |
Without ankle loading |
Without ankle loads postural sway and weight symmetry using posturography and muscle activation using wireless EMG will be calculated in stroke patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with sub-acute or chronic stroke
2)Patients who can stand with or without supervision
3)MMSE- ≥ 24
4)Patients with unilateral stroke
5)People who have had single episode of stroke
6)Functional vision and hearing
|
|
| ExclusionCriteria |
| Details |
1)Patients with any musculoskeletal disorders and injury of lower limb
2)Patients who had undergone recent lower extremity surgery
3)Patients with open wounds on ankle
4)Additional neurological or psychiatric disorders
5)Vestibular diseases
6)Uncooperative patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Postural sway using Posturography
- Sway velocities in the mediolateral and in the
anteroposterior directions will be calculated in mm/sec, and
- Velocity moment will be calculated in mm²/sec
|
4 time points:
Without weight on ankle for 30 seconds
With 0.5 kg weight on ankle for 30 seconds
With 1 kg weight on ankle for 30 seconds
With 2 kg weight on ankle for 30 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Weight symmetry using Posturography
2.Muscle activation using wireless EMG
- RMS of the electromyographic signal in mV will be calculated
|
4 time points:
Without weight on ankle for 30 seconds
With 0.5 kg weight on ankle for 30 seconds
With 1 kg weight on ankle for 30 seconds
With 2 kg weight on ankle for 30 seconds |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
01/06/2017 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will be screened
and selected based on the inclusion/exclusion criteria. The selected patients
will be explained in brief about the study procedures and the tests and then an
informed consent will be obtained from them. After briefing them,
individual’s demographic details will be recorded, followed by assessment of
the outcome measures. The outcome measures, that is, postural sway
and lower limb muscle activation will be assessed using Static Posturography
(Good Balance system, Metitur Ltd, Jyvaskyla, Finland) and Wireless
Electromyography (DELSYS Trigno wireless EMG system, AD instruments, USA. 2016)
respectively in the following 4 conditions: Without weight above
paretic ankle -With 0.5 kg weight above
paretic ankle
-With 1 kg weight above
paretic ankle
-With 2 kgs weight above
paretic ankle
The above test sequence
will be randomized using lottery method.
Surface
EMG electrodes will be applied on the following muscles:
a) Tibialis anterior-
over the area of greatest muscle bulk just lateral to the crest of the tibia on
the proximal half of the leg(11)
b) Soleus- on the
posterior aspect of the leg, 5 centimeters below the insertion of gastrocnemii(12)
c) Lateral gastrocnemius-
over the area of greatest bulk on the lateral calf(11)
d) Medial gastrocnemius-
over the area of greatest bulk on the medial calf(11)
After
applying the electrodes, the weight cuff corresponding to the weight selected
by the patients will be applied over the paretic ankle and then the patients
will be asked to stand on force plate with their legs spread at shoulder width
and looking straight ahead for 30 seconds. Then postural sway velocity and
velocity moment of subjects in the standing posture will be measured, and
simultaneous in that 30 seconds RMS of the electromyographic signal in mV of
tibialis anterior, soleus, lateral gastrocnemius and medial gastrocnemius will
be calculated using a wireless EMG. The outcome measures will be calculated
with eyes open and eyes closed. Similarly, all the other test conditions will
be done, except for the test condition ‘without weight over paretic ankle’
where without any weight cuff on the patient’s paretic ankle the outcome
measures will be calculated. Rest period of 10 minutes will be provided between
each test condition. |