| CTRI Number |
CTRI/2024/03/063569 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| 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
|
Forward reaching exercises for the weak muscles of leg and thigh after stroke in modified sitting. |
|
Scientific Title of Study
|
Effects of forward reach on paretic lower extremity muscles of patients with stroke in a modified sitting position |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nuwagi Buay Tluway |
| Designation |
MPT Neuro sciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Faculty of physiotherapy 2nd floor
Chennai
TAMIL NADU
600116
India |
| Phone |
7845463855 |
| Fax |
|
| Email |
nuwagi.buay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika C. M |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research. (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841376961 |
| Fax |
|
| Email |
radhikacm@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nuwagi Buay Tluway |
| Designation |
MPT Neuro sciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Faculty of physiotherapy 2nd floor
Chennai
TAMIL NADU
600116
India |
| Phone |
7845463855 |
| Fax |
|
| Email |
nuwagi.buay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Nuwagi Buay Tluway SELF |
| Address |
Sri ramachandra institute of higher education and research |
| 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 Nuwagi Buay Tluway |
Sri Ramachandra Hospital |
department of neurology. C5, D5, B5 and B4 wards
Chennai
TAMIL NADU |
7845463855
nuwagi.buay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMACHANDRA ETHICS COMMITEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified sitting forward reaching |
1.patient in sitting position with only paretic lower limb supported on stool.
2.forward reaching a distance of 1.5 arm length 20 times and twice per day for 8 days |
| Comparator Agent |
normal sitting |
1. patient in sitting position with both lower limbs supported on stool.
forward reaching a distance of 1.5 arm length 20 times, twice per day for 8 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed diagnosis of stroke within the acute phase in MCA territory, as determined by medical records and clinical assessment.
2.Participants with the age between 18 and 75 years.
3.Participants with a stable medical condition that allows for participation in the study and the prescribed exercise regimen.
4.Ability to sit for at least 30 seconds, understand and follow instructions related to the supported sitting reaching tasks.
5.Lower limb Brunnstrom score of at least 2
|
|
| ExclusionCriteria |
| Details |
1.Patients with co-existing (premorbid and comorbid) neurological conditions other than stroke were excluded.
2.Individuals with severe cognitive impairments that prevent them from understanding and following task instructions were excluded.
3.Patients with severe medical complications that contraindicate participation in physical exercises, such as uncontrolled hypertension or cardiovascular instability, were excluded.
4.Individuals with mobility limitations or impairments unrelated to stroke that significantly affect their ability to perform the prescribed exercises were excluded.
5.Patients who do not provide informed consent to participate in the study were excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN MUSCLE RECRUITMENT FOR THE TIBIALIS ANTERIOR AND QUADRICEPS MEASURED BY SURFACE ELECTROMYOGRAPHY (EMG) AT THE END OF INTERVENTIONS |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
31/05/2024 |
| 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)
Modification(s)
|
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
|
Study
Procedure
The study will be conducted
in four steps:
Step 1 – screening of the
stroke patients in the wards for the inclusion criteria and briefly explain the
study and obtaining the consent from participants.
All patient with stroke will be screened for inclusion to the
study from neurology department of SRMC. Explain and demonstrate rehabilitation
program that incorporates forward reaching at distance of one and half of the
arm length, with only paretic limb supported in experimental group and both
lower limbs supported in control group will be to those who qualifies for the
study followed by obtaining their consent for voluntary participation.
Step 2 – randomization
and baseline data collection.
The subjects will be recruited randomly for the study based
on inclusion and exclusion criteria.
They will be randomly sampled and concealment allocation to
experimental and control group.
Participants who provide consent will be explained about the
study and exercise protocol for sEMG.
Baseline data will be collected by blinded assessor on
participants’ demographics, muscle recruitment patterns, including average amplitude of
muscle contraction for the tibialis anterior and quadriceps on paretic lower
limb.
Step 3 – Implementation and Monitoring
Appropriate training will be provided to participants
regarding the forward reach exercise program. 20 repetitions per sessions will
be done under therapist’s supervision. Exercise will be conducted twice per day
for 8 days.
The surface EMG electrodes
will be attached to the tibialis anterior and quadriceps on the paretic limb
following standard SENIAM EMG electrode placement guidelines. EMG recording
equipment will be started to collect data during the exercise. Safety monitoring and feasibility will be
included in the study.
Post intervention assessment will be conducted at the end of 8
days of the study.
Step 4 – Data analysis
The collected data will be stored
safe in computer with password and interpreted using statistical analysis,
Repeated Measures
Analysis of Variance (ANOVA) will be used to assess changes over time from
pre-intervention to post-intervention within each group and compare these
changes between groups. |