| CTRI Number |
CTRI/2025/07/091376 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Translation, Validation and Reliability Testing of TFMA-UE Scale |
| Study Design |
Other |
|
Public Title of Study
|
Testing and Validating the Hindi Version of a Stroke Recovery Scale of Arm and Hand Function |
|
Scientific Title of Study
|
Hindi Translation, Validation and test retest reliability testing of the telematic fugl meyer assessment scale-upper extremity in stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Neuro OPD, Ground Floor, Room No.1, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA
133207
India |
| Phone |
7668094845 |
| Fax |
|
| Email |
muskanmittal941@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Chatarjee |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Neuro OPD, Ground Floor, Room No. 1, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA
133207
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhasishphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhasish Chatarjee |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Neuro OPD, Ground Floor, Room No. 1, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
HARYANA
133207
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhasishphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurophysiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Medical Sciences and Research, Maharishi Markandeshwar (deemed to be university), Mullana, Ambala, Haryana 133207 |
|
|
Primary Sponsor
|
| Name |
Muskan |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
|
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Subhasish Chatarjee |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Muskan |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, |
Neuro OPD, Ground Floor, Room No. 1, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA |
7668094845
muskanmittal941@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
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 |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Stroke patients with acute or sub-acute or chronic suffering from ischemic or haemorrhagic stroke were recruited.
cerebrovascular accident CVA stroke brain attack
|
|
| ExclusionCriteria |
| Details |
Musculoskeletal disorders.
Patients with poor general health including neurological conditions.
Segmentary absence of a limb.
Uncontrolled comorbidities dementia any mental. deficit which may affect cognitive performance. Function limitation as a result of moderate to severe pain and inability to follow the verbal instructions by the assessor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Telematic Fugl Meyer Upper Extremity Assessment Scale (TFMA-UE) |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
02/08/2025 |
| 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="8"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The Telematic
Fugl-Meyer Upper Extremity Assessment (TFMA-UE) in stroke is an index to assess the sensorimotor
impairment in individuals who have had stroke. This scale has a standardized
assessment test for post-stroke recovery in their paper titled “The post-stroke
hemiplegic patient: A method for evaluation of physical performance”. It is now
widely used for clinical assessment of motor function to evaluate the extent of
motor impairment and the progress of rehabilitation in stroke patients and
those with similar upper extremity motor deficits and assesses various
functions, including movements, coordination, and reflexes, to determine the
level of disability and track improvements over time. Telematic assistance has become indispensable in
recent years. The increased prevalence of Acquired brain injury and the sequels
it causes, requires long–lasting multidisciplinary treatments. Validated tools
to assess the evolution of the disabilities and limitations of this pathology
are essential to individualize and prescribe adapted treatments. The aim has
been to create the telematic version of the Fugl Meyer Assessment-Upper
Extremity Motor Function (TFMA-UE) Spanish scale and its adaptation to the remote
assessment of neurologic patients. The purpose of this study is to translate into the Hindi version of (TFMA-UE)
and to evaluate its validity and test-retest reliability. A cross-sectional study. The study method includes the translation of the (TFMA-UE) in Hindi
language from English by 2 translators (i.e.) T1 and T2 from medical and
non-medical background respectively. The recording observer then takes a seat
to create a T12 version of the translated questionnaire. The reverse translation from the T12 form
to the previous form is now being done. Then, an expert panel analyses all the
stages and all of the questionnaire items that the translated form of the
questionnaire is free of errors, allowing it to be field tested. Evaluation of
content’s validity is done. The pre-final form is then fully tested on
patients, and the scale’s validity is reported. Finally, the translated
questionnaire version will be analyzed by the ethics committee. The test-retest
reliability is computed by measuring subjects at two distinct occasions and
then computing the correlation. |