| CTRI Number |
CTRI/2024/05/067028 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of muscle activity across Neurological conditions |
|
Scientific Title of Study
|
Fatigability thresholds of upper & lower extremity muscles across Neurological conditions: A Comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumalya Sen |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Room number 215, Department of physiotherapy, second floor,
Manipal College Of Health Professions, Manipal Academy of
higher education, Madhav Nagar, Manipal, Udupi, Karnataka-
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9679917842 |
| Fax |
|
| Email |
soumalya.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manikandan Natarajan |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Room number 215, Department of physiotherapy, second floor,
Manipal College Of Health Professions, Manipal Academy of
higher education, Madhav Nagar, Manipal, Udupi, Karnataka-
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil Kumaran D |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Room number 215, Department of physiotherapy, second floor,
Manipal College Of Health Professions, Manipal Academy of
higher education, Madhav Nagar, Manipal, Udupi, Karnataka-
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Manipal College Of Health Professionals, Manipal Academy of higher education, Manipal, Udupi, Karnataka India- 576104
|
|
|
Primary Sponsor
|
| Name |
Soumalya Sen |
| Address |
Department of physiotherapy, second floor,
Manipal College Of Health Professions, Manipal Academy of
higher education, Madhav Nagar, Manipal, Udupi, Karnataka-
576104 |
| 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 Manikandan Natarajan |
KASTURBA HOSPITAL |
102 N1 Physiotherapy
OPD, Baliga Block,
Kasturba Hospital,
Madhav Nagar Manipal,
Udupi, Karnataka Pin -576104
Udupi
KARNATAKA |
9886898064
mani.kandan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Neurological patients referred to physiotherapy
2)Able to understand command and cognitively sound (Montreal Cognitive Assessment more than or equal to 26)
3)Able to voluntary move their upper & lower limb (Muscle power more than or equal to 3) or its equivalent Eg: Motricity index more than or equal to 19 in stroke patients
|
|
| ExclusionCriteria |
| Details |
1)Individuals with other systemic conditions like asthma
2)Individuals with other deformity like Rheumatoid arthritis
3)Presence of depression or sleep disorders
4)Skin diseases that prevent placement of EMG electrodes
5)Any brain surgery and previous surgical history
6)Any condition that precludes assessment of Maximum Voluntary Contraction with EMG, such as CRPS in stroke
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to task failure at each level (60, 40 and 20% Maximum Voluntary Contraction)
|
Baseline Assessment will be done at the time of recruitment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Fatigue Scale(VAFs) |
Baseline Assessment will be done at the time of recruitment
|
|
|
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)
|
20/05/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
The goal of this study is to determine the threshold of fatigability in upper and lower extremity muscles across neurological conditions. The participants will undergo a fatigability assessment, which will raise awareness of various kinds of work and activities that are appropriate for people recovering from neurological conditions. The side impacted by neurological disorders will be identified first. Only the affected side will be evaluated in situations involving unilateral side involvement, and only the most affected side will be evaluated in cases of bilateral side involvement. When there is symmetrical and bilateral involvement, the dominant side will be assessed. Shoulder flexors, elbow flexors of the upper limb, and knee flexors & extensors of the lower limb will be assessed in a participant. Using a visual analogue fatigue scale, the baseline level of fatigue will be determined and recorded. Using an hand-held dynamometer, the participants will be asked to contract a chosen muscle as much as possible in an isometric manner against resistance. The percentage of Maximum Voluntary Contractions from the surface Electromyography and the peak amplitude from the dynamometer will be recorded. The degree of fatigue at that particular time will be graded using a visual analogue fatigue scale. Participants will get ample opportunity to rest in order for their level of fatigue to return to the baseline.The participants will subsequently be given three different threshold levels to contract their muscles at: 60%, 40%, and 20% MVC. Participants will have to keep contracting their muscles at each level until the task ends on their own volition or, if that happens before five minutes, then until then. At each threshold level, the duration of time until task failure and the degree of fatigue will be recorded. |