| CTRI Number |
CTRI/2024/04/065205 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of using soft robotic hand glove and functonal electrical stimulation for the improvement of hand activities in stroke patients |
|
Scientific Title of Study
|
Effectiveness of Using Soft Robotic Hand Glove Over Functional Electrical Stimulation for Improving Hand Function in Stroke Patients |
| Trial Acronym |
Robotic Hand Gloves and FES in stroke for improving hand function |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Snehal S. Samal |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923622945 |
| Fax |
|
| Email |
snehalsamal11@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Snehal S. Samal |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923622945 |
| Fax |
|
| Email |
snehalsamal11@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Snehal S. Samal |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923622945 |
| Fax |
|
| Email |
snehalsamal11@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe,) Wardha, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Snehal S Samal |
Acharya Vinoba Bhave Rural Hospital |
Department of Neurophysiotherapy, Datta Meghe Instituite of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA |
9923622945
snehalsamal11@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conservative treatment |
- Group –A: - The treatment planned will be of five sessions per week for a total of 30 sessions for 6 weeks.Functional Electrical Stimulation and conservative treatment.
- (1) Identify the functions to be trained (reaching and/or grasping).
- (2) Select the order of the tasks to be re-trained: typically, start with gross motor tasks (proximal muscles) in early stages of therapy followed by fine movement control (distal muscles).
- (3) For each task identify the muscles to be stimulated: at any given time either only simple reaching or grasping tasks such as touching mouth or palmar grasp can be trained or more complex tasks such as reaching + grasping can be trained based on number of channels available for stimulation.
- (4) First identify the optimal electrodes positioning: For a given function, find the motor point; the electrode position where a maximal contraction is obtained with minimum stimulation current delivered.
- (5) Apply self-adhesive electrodes over the motor points of the muscles identified.
- (6) Identify and record the different stimulation thresholds: Identify sensory threshold (when the patient feels the current for the first time), motor threshold (when a palpable or a visible contraction is produced), functional threshold (when the desired functional movement is produced) and maximum threshold (beyond which the patient does not tolerate an increase in current amplitude).
- (7) Explain to the patient what to expect when the FES in turned on.
- (8) Turn on the stimulator and adjust the current intensities for all muscles to the levels determined previously (intensity should not exceed the determined maximum threshold).
- (9) Instruct the patient that she/he has to make an active attempt to perform the intended movement.
- (10) Repeat this protocol 10–15 times. Then, select another protocol and perform the next task for 5–7 min or as appropriate for that task. Execute 3–6 different protocols in a 1-h session
- (11) The maximum stimulation parameters where chosen as follows: for Ch1 is the maximum pulse width was 256 µs with 9 mA current; for CH2 -the maximum pulse width was 305 µs with 10 mA current.(13)
- Group –B: Soft Robotic Gloves and conservative treatment.
- 1. Dice in the box- To grab the dice and place them inside a box, and vice versa, take as well as to take them out of the box and place them on the table.
- 2. Build a pyramid- To grab the dice and place them in order to build a pyramid on the table. Once the exercise will complete, the dice has to be returned to their starting point.
- 3. Build a column- To grab the dice and place them in order to build a column on the table. Once the exercise will complete, the dice has to be returned to their starting point.
- 4. Peg board activity- To grasp the different size and shapes of the pegs from the board and remove it from board and vice-versa.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The first onset of stroke.Stage 2, or lower on the Modified Ashworth Scale.Mini Mental Scale Examination Score less than 18.Participants diagnosed as stroke through MRI with Brunnstrom hand recovery stage 2 and 3. Participants comprised hemiplegia in the past 3 months.
|
|
| ExclusionCriteria |
| Details |
Participants who has a history of recurrent stroke.
Participants with age more than 70 years.
Any severe limitation that would limit the subject’s participation in the exercise program or interfere with functional assessments performed in this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth scale.Fugl - Meyer assessment upper extremity.Brunstrom grading of Hand function.
|
Base line, week 3 and week 6. Modified Ashworth scale.Fugl - Meyer assessment upper extremity.Brunstrom grading of Hand function.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Box & blocks test
Nine hole peg test
|
Baseline, week 3 & week 6 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="1"
Months="0"
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
|
Various studies have been done about the robotic gloves which evaluated
them according to their mechanical structure, control system, and clinical
applications. With respect to importance of improving hand function in patients
with stroke, there is a need to gain more comprehensive information regarding
capability of robotic gloves toward restoring hand function of stroke patients.
Few studies have been conducted on the therapeutic effects of these devices in
patients with stroke. Therefore, the present research is conducting with the
aim of improving motor recovery and functional abilities of the paretic hand in
patients with stroke |