| CTRI Number |
CTRI/2024/12/077921 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| 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
|
Impact of Electrical Stimulation Combined with Special Movement Exercises on Sitting Balance and Trunk Control in Stroke Survivors. |
|
Scientific Title of Study
|
Effect Of Triggered Functional Electrical Stimulation In Conjunction With Proprioceptive Neuromuscular Facilitation On Sitting Balance, Trunk Control And Functional Independence In Individuals With Stroke. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Jain |
| Designation |
Postgraduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation Department of Neurorehabilitation, 2nd Floor, Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
110070
India |
| Phone |
9870401511 |
| Fax |
|
| Email |
jharshita0501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Stuti Khanna |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation Department of Neurorehabilitation, 2nd Floor, Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
110070
India |
| Phone |
9891847488 |
| Fax |
|
| Email |
sehgalstutiss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshita Jain |
| Designation |
Postgraduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation Department of Neurorehabilitation, 2nd Floor, Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
110070
India |
| Phone |
9870401511 |
| Fax |
|
| Email |
jharshita0501@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation Department of Neurorehabilitation |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Sector C, Vasant Kunj, New Delhi - 110070 |
| 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 |
| Harshita Jain |
Indian Spinal Injuries Centre |
Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI |
9870401511
jharshita0501@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Indian Spinal Injury Centre |
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 |
| Comparator Agent |
Effect Of Sham Triggered Functional Electrical Stimulation In Conjunction With Proprioceptive Neuromuscular Facilitatio |
The individuals in the intervention group will receive sham triggered FES stimulation (0 amplitude) in conjunction with PNF exercises. The FES will be provided via Walkex functional electrical stimulation device to the respective muscle in play while performing various PNF techniques and flexion and extension patterns. The following techniques : alternating isometrics, rhythmic stabilization, slow reversals and patters: chopping (flexion pattern), lifting (extension pattern). The patient will receive the intervention for 30 mins per day 5times/week for 4 weeks (in addition to conventional physiotherapy treatment) |
| Intervention |
Effect Of Triggered Functional Electrical Stimulation In Conjunction With Proprioceptive Neuromuscular Facilitation |
The individuals in the intervention group will receive triggered FES stimulation in conjunction with PNF exercises. The FES will be provided via Walkex functional electrical stimulation device to the respective muscle in play while performing various PNF techniques and flexion and extension patterns. The following techniques : alternating isometrics, rhythmic stabilization, slow reversals and patters: chopping (flexion pattern), lifting (extension pattern). The patient will receive the intervention for 30 mins per day 5times/week for 4 weeks (in addition to conventional physiotherapy treatment) |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Hemiparesis with first stroke.
2. Duration ˃3 months.
3. Age: 50-70 years.
4. Those who can’t maintain unsupported sitting balance for five minutes.
5. Individuals with ≥ 4 stage of Brunnstorm motor recovery scale.
6. Mini‑Mental State Examination score ˃24.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with severe aphasia or cognitive impairment.
2. Subjects who were suffering from known case of brain tumor, head injury, infective conditions of brain, or from other neurological diseases.
3. Subjects with unilateral neglect.
4. Subjects with vestibular organ diseases.
5. Those who have electrical stimulation contraindication.
6. History of diagnosed musculoskeletal disorders of the trunk.
7. Subjects with implanted pacemakers or defibrillators. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sitting Balance (Sitting Balance Scale)
Trunk Control (Trunk Impairment Scale and Postural Assessment Scale for Stroke) |
Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Independence (Functional Independence Measure ) |
Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a debilitating neurological condition
characterized by sensory, motor, autonomic, and/or bowel dysfunction caused by
a lesion to the brain that leads to abnormal sitting balance, trunk control deficits and functional
dependence. As most of the functional and other day to day activities performed
are carried out in sitting position, sitting balance and trunk control is
considered as a prerequisite for effective performance of day-to-day tasks and
other activities.
Proprioceptive
neuromuscular facilitation (PNF) and Functional electrical stimulation (FES) are
two promising interventions that have shown to improve sitting balance, trunk
control and functional independence in individuals with various neurological
disorders, but their combined effectiveness has not been explored yet. Hence
this research aims to find their effectiveness on sitting balance, trunk
control and functional independence in individuals with stroke.
Patients will be screened based on inclusion and exclusion
criteria. They will be enrolled into 2 groups with the help of random
allocation software. One group will receive Triggered FES in conjunction with PNF along with conventional
physiotherapy 5 times a week for 4 weeks. Whereas the second group will receive
sham stimulation in
conjunction with PNF along with conventional physiotherapy for the same
duration.
The outcome measurements will be done by using the following
scales: Sitting Balance Scale (SBS), Trunk Impairment Scale (TIS), Postural
Assessment Scale for Stroke (PASS) and Functional Independence Measure (FIM) . Variations
in outcome measurement scores: pre, post and 1 month follow up post completion will
help us find out the effectiveness of triggered functional electrical stimulation in conjunction with
proprioceptive neuromuscular facilitation on sitting balance, trunk control and
functional independence and in individuals with stroke. |