| CTRI Number |
CTRI/2024/10/075632 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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To see the effect of advanced physiotherapy current treatment for leg muscles during cycling on the walking and leg functions in persons with stroke " |
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Scientific Title of Study
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A Randomized Controlled Trial to Assess the Effectiveness of Functional Electrical Stimulation with Cycling on Motor Performance among Patients with Hemiparetic Middle Cerebral Artery Stroke
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| nil |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brammatha A |
| Designation |
Professor |
| Affiliation |
Phd Scholar under The Tamilnadu Dr M G R Medical University, Centre RVS College of Physiotherapy |
| Address |
Room number - 019
Department of Advanced PT in Neurology
KMCH College of Physiotherapy,
Affiliated to The Tamilnadu Dr M G R Medical University,
Kalapatti Road
Coimbatore -48
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9751509033 |
| Fax |
|
| Email |
brammatha@yahoo.co.in |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Edmund M.D,Couto |
| Designation |
Head of Department |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Room number 0001
Department of Physical Medicine and Rehabilitation
Kovai Medical Center and Hospital
Avinashi Road,Coimbatore
Room number 0001
Department of Physical Medicine and Rehabilitation(PMR)
Kovai Medical Center and Hospital
Avinashi Road,Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9600601548 |
| Fax |
|
| Email |
dredmund@kmchhospitals.com |
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Details of Contact Person
Public Query
|
| Name |
Dr M .K Franklin Shaju |
| Designation |
Professor and Principal / Phd Guide |
| Affiliation |
RVS College of Physiotherapy, Affiliated to tThe Tamilnadu Dr M G R Medical University |
| Address |
Room Number -1
Principals office
Department of Neurology/Phd Centre of The Tamil Nadu Dr MGR Medical University
RVS College of Physiotherapy
242-B,
Trichy Road
Coimbatore - 641402
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9843671222 |
| Fax |
|
| Email |
franklin@rvsgroup.com |
|
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Source of Monetary or Material Support
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| Kovai Medical Center and Hospital , Avinashi road,Coimbatore |
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Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
Kalapatti road
Coimbatore-641048 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Edmund M D Couto |
Kovai Medical Center and Hospital |
Room Number 0001, Department of Physical Medicine and Rehabilitation,Kovai Medical Center and Hospital,Avinashi Road,Coimbatore-641014
Coimbatore
TAMIL NADU |
09600601548
dredmund@kmchhospitals.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
– FES with cycling |
Medically stable InPatient’s from the KMCH Hospital Diagnosed by the Neurologists as Middle Cerebral Artery Stroke and referred for stroke rehabilitation will be recruited for the study. Patients who fulfill the selection criteria and showing willingness to participate in the study after providing Informed consent will be selected. Pretest measures will be taken prior to the interventions .• Intervention consists of daily 25 minutes sessions for 15-20 sessions, during which the patients will perform FES Cycling for about 15 minutes , warm up and cool down each for 5 minutes |
| Comparator Agent |
Control group |
standard post stroke exercise
Basic Exercise 20 -25 minutes
•Supine Position: Passive or Active assisted range of movements and stretching exercises to upper limb and lower limb
•Bed Mobility – supine to side lying , bridging
•Supine to sitting transfer training
•Exercises in Sitting – static and dynamic weight shifting Exercises
•Sit to Stand training with support and various foot positions
•Selective Functional Strengthening Exercises
•Upper limb Reaching activities
•Exercises in Standing – static and dynamic weight shifting Exercises
Advanced Exercises
•Sit-to-stands without support
•One leg standing with and without support
•Stepping over foot stools of different heights using both limbs
•Sideways and forward walking within parallel bar
•Postural Control training on a therapeutic ball with forward and side reaches,
•Standing with eyes closed, and tandem standing which progressed to tandem walking
•Treadmill walking for 10–15 min at a self-selected speed and gradually increased.
•For endurance training and progression figure-of-eight walking, obstacle crossing, and stair climbing
Education about exercise and its significance for adherence to exercise and prevention of complications
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Inpatients who are clinically diagnosed with Middle Cerebral Artery Stroke and referred for post stroke rehabilitation
2.Both males and females in age group 45-70 years.
3.Stroke of duration within first to third week.
4.Both Ischaemic and Haemorrhagic Stroke patients
5.Brunnstrom voluntary stage II and 1V for affected lower limb
6.Able to sit with support and not an independent ambulator
7.Spasticity in Quadriceps and Hamstrings less than 2 according to Modified Ashworth Scale
.
8.Able to understand and follow commands
9.Adequate sensory function to understand perception of current and cycling.
10.Cooperative and willing to participate in this study.
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| ExclusionCriteria |
| Details |
1.Recurrent stroke, Patients with Hemi spatial neglect or Pushers syndrome.
2.Contraindications for lower limb mobilization like DVT
3.History of any other musculoskeletal problems of lower limb and limited passive joint range of motion which will hinder the interventions and exercise
4.Patients with implants such as pace makers, metal implants over affected lower limb ,skin lesions over stimulation site, Sensory disturbances over the dorsal or ventral aspect of thigh.
5.Patients with any other Neurological disorders.
6.Global aphasia and Receptive dysphasia.
7.Medically unstable Eg: Uncontrolled Cardiac arrhythmias. reduced cardiac output, Postural hypotension
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
Motor recovery measures
1.Fugl-Meyer Assessment Scale Lower Limb Component -For Motor performance (Scores)
2.Functional Ambulation Category-Walking Performance(Scoring)
3.Five Times Sit to Stand Test - for lower limb functional strength (Timed in seconds)
4.Upright Motor Control Test -Voluntary control of affected lower limb (Scoring)
|
Baseline /Pre test- 0 weeks
Post Test -After 15 sessions of training 3rd week
Follow up - 6th week |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Gait speed |
6th week for ambulatory persons |
|
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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In our country the stroke population are mostly the bread-winners of their family, so considering that it is important to augment early standing and walking.The short inpatient rehabilitation of the stroke patient with hemiparesis/hemiplegia has to be augmented for better lower limb motor performance and early walking to harness the Neuroplasticity of brain. Recently Functional Electrical Stimulation (FES) is being used to either replace or retrain function. Functional electrical stimulation (FES) can be combined with cycling to generate the active movement of paralyzed muscles.The use of an FES approach in the early phase of stroke rehabilitation for therapeutic purposes facilitates the achievement of better functional output in a shorter period of time. An electrical stimulation integrated along with functional activity can significantly increase quadriceps recruitment in persons recovering from stroke. Wandel et al 2000 in their study reported strong relationship between leg motor power after 7 days of stroke and subsequent recovery of gait. They found that post stroke ..individuals who started therapy earlier are more likely to have a better gait recovery.
Research Question Population- In Patients with Middle Cerebral Artery Stroke who are not able to stand and walk Intervention-Functional Electrical Stimulation with Cycling Comparison- Standard post stroke Exercise Outcome of interest- Motor performance Measures AIM OF THE STUDY To determine changes on Motor Performance variables after Functional Electrical Stimulation Cycling(FESC) compared to conventional exercises only among patients with hemiparetic Middle Cerebral Artery Stroke Medically stable InPatient’s from the KMCH Hospital Diagnosed by the Neurologists as Middle Cerebral Artery Stroke and referred for stroke rehabilitation will be recruited for the study. Patients who fulfill the selection criteria and showing willingness to participate in the study after providing Informed consent will be selected. Pretest measures will be taken prior to the interventions . The selected patients will be randomly allocated to 30 in each group. – FES Cycling (Experimental Group) – Conventional Exercises (Standard therapeutic and task based exercises) (Control Group) After Baseline Measures are taken the Exercise Protocol will be implemented for 3 Weeks. Post Test(T1) will be measured after 3 weeks with the set of selected motor performance measures.
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