| CTRI Number |
CTRI/2024/08/072700 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| 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
|
Combined effects of Mirror Therapy and Functional Electrical Stimulation on Hand Dexterity and Quality of Life in Stroke Survivors: A Clinical Randomized Trail |
|
Scientific Title of Study
|
Combined effectiveness of Functional Electrical Stimulation with Mirror Therapy on hand dexterity and quality of life in recovering stroke individuals. A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akansha sarode |
| Designation |
MPT student |
| Affiliation |
parul institue of physiotherapy |
| Address |
room no. 309 3rd floor parul institue of physiotherapy, parul university post. limda waghodia vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8160546590 |
| Fax |
|
| Email |
akansha26sarode@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitali Shah |
| Designation |
associate professor |
| Affiliation |
Parul Institute of Physiothearpy |
| Address |
room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia,
vadodara, India
room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia,
vadodara, India
Vadodara
GUJARAT
391760
India |
| Phone |
9998107262 |
| Fax |
|
| Email |
chaitali.shah@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitali Shah |
| Designation |
associate professor |
| Affiliation |
Parul Institute of Physiothearpy |
| Address |
room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia,
vadodara, India
room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia,
vadodara, India
Vadodara
GUJARAT
391760
India |
| Phone |
9998107262 |
| Fax |
|
| Email |
chaitali.shah@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia,
vadodara, Gujarat, India
391760 |
|
|
Primary Sponsor
|
| Name |
Akansha Sarode |
| Address |
room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia, vadodara, India |
| 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 |
| Dr Chaitali Shah |
Parul Sevashram Hospital |
room no.309, 3rd floor, Parul Institue of Physiotherapy, Parul University, limda, waghodia, vadodara, India
Vadodara
GUJARAT |
9998107262
chaitali.shah@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional electrical stimulation with mirror therapy |
Frequency 5 days per week for 4 weeks [20 Hz]
Duration 30 mins
Functional electrical stimulation (FES) is the application of electrical current to excite a tissue and replace function which is lost in individuals with neurological impairment [10]. It acts as tool for restoring the motor skills of stroke survivors by applying electrical impulses through the skin surface to stimulate targeted nerves , thereby initiating the movements in paretic muscles[3]. In hemiparetic limb FES has the potential to generate functional arm and hand movements in various ways. Mirror therapy is an intervention that improves the functional movements of the paretic limb. Visual feedback is used for encouraging patients to concentrate on the movements of their non-paretic limbs[4].Regularly practicing certain movements such as hand exercises during mirror therapy can help in strengthening
the pathways that control hand functions |
| Comparator Agent |
Surged faradic with mirror therapy |
Frequency 5 days per week for 4 weeks [50-100 Hz]
Duration 30 mins
Surge faradic stimulation involves using electrical pulses to stimulate muscle contractions, which can help in strengthening muscles and improving motor function1. When combined with mirror therapy, where a mirror is used to create a reflection of the unaffected hand to trick the brain into thinking both hands are moving, it can enhance motor recovery and dexterity2. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with stroke and having hand function affection
2. No sensory impairment
3. Voluntary consent to participate in the study
4. Voluntary control is equal to 3 or above according to Brunstorm stage of recovery
5. Fugl Meyer score between 11-40
6. Disease duration between 1-6 months
|
|
| ExclusionCriteria |
| Details |
Any visual perception disorders
2. Patient having confusion or other severe consciousness problem
3. Clinical evidence of limited passive joint range of motion at wrist joint
4. Unable to follow command |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl meyer scale for upper extremity
9 Hole peg test |
5 days/week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke specific quality of life |
5 days/week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Stroke often leads to impaired hand function and decreases manual dexterity leading, limiting activities
of daily living and impacting quality of life. People note lower perceived quality of life with reduced hand dexterity. About 50% of stroke survivors have impaired upper limb and hand function in the chronic phase, which
impacts strongly on activities of daily living and on independence. Due to the affection of activities of daily living the quality of life is also affected in stroke individuals. In 1 study it was found that it is difficult to achieve motor function improvement by electrical
stimulation alone in patients lacking active movements. In another study it was found that although FES can improve range of motion it does not improve
purposeful movements. Placing an emphasis on motor function might be considered to result in inadequate consideration of
cognitive aspects, but reorganization of brain can be enhanced when cognitive aspects and physical
functions are adequately addressed. Mirror therapy may provide suitable intervention for providing that cognitive aspect. In order to gain the hand dexterity both strength of hand and grip is required hence the need to combine
both FES and MT. Although there are many studies focusing on hand dexterity in stroke patients, very few studies have
been done that explains the combined effect of FES and MT on both hand dexterity and quality of life in
recovering stroke individuals |