Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605612
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Development and Validation of the FBIndex to Determine the Risk of Falls for Patients with Neuromuscular Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Validation of the FBIndex to Determine the Risk of Falls for Patients with Neuromuscular Disorders
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FBIndex
Brief Summary:
Currently there are no standardised fall risk scores or guidelines on when to use appropriate assistive gait devices AGDs for people with neuromuscular disorders NMDs There is a clear medical unmet need to provide a battery of appropriate locomotor gait assessments to determine the risk of falling for patients with NMDs and give clear guidelines to prescribe an appropriate AGD
The primary goal is to confirm whether the clinical battery assessments Heel-Rise Test HRT Chair-Rise Test CRT Semi-tandem Stand STS Trunk-Rise Test TRT Foot-Tapping Test FTT Timed Up and Go TUG 10-Meter-Walk Test 10MWT and 6-Minute-Walk Test 6MWT can be validated and generalized to other NMD target populations that meet broader eligibility criteria based on used clinical assessments The second objective of this project is to provide intra- and inter-observer reliability and test-retest reliability of included clinical assessments used to determine the risk of falling for patients with NMDs Finally all data will be compared with norm data from the healthy population n15 collected retrospectively
The primary goal is to confirm whether the clinical battery assessments Heel-Rise Test HRT Chair-Rise Test CRT Semi-tandem Stand STS Trunk-Rise Test TRT Foot-Tapping Test FTT Timed Up and Go TUG 10-Meter-Walk Test 10MWT and 6-Minute-Walk Test 6MWT can be validated and generalized to other NMD target populations that meet broader eligibility criteria based on used clinical assessments The second objective of this project is to provide intra- and inter-observer reliability and test-retest reliability of included clinical assessments used to determine the risk of falling for patients with NMDs Finally all data will be compared with norm data from the healthy population n15 collected retrospectively
Detailed Description:
The NMD people are characterised by a complex muscle weakness caused by a combination of different factors These include reduced endurance lack of explosive muscle force and power intramuscular strength coordination and reduced balance Those parameters need to be considered when developing an appropriate fall risk score The combination of short muscular function and balance assessments with short clinical scores can be a new valid approach to evaluating the patients risk of falling In addition it assists in creating a quick checkup for prescribing an appropriate assistive device
In the first part feasibility study of this project the following force plate tests were identified as suitable to assess muscle power force and balance variables Heel-Rise Test HRT Chair-Rise Test CRT Semi-tandem Stand STS Trunk-Rise Test TRT Foot-Tapping Test FTT They were used as predictors to assess patients muscle weakness and disability In addition to muscle power and force data collected on the force plate a second rater manually evaluated the time required to perform this test using a stopwatch Additionally three separate tests Timed Up and Go TUG 10-Meter-Walk Test 10MWT and 6-Minute-Walk Test 6MWT have been evaluated separately as standard care procedures The TUG 10MWT and 6MWT have been used to assess remaining motor skills endurance walking speed and coordination that cannot be covered by HRT CRT STS TRT and FTT As a third parameter used for correlation analysis two risk of fall scales Falls Efficacy Scale International FES-I and Morse Fall Scale MFS have been used The found data from the feasibility study which is planned to be published suggest a moderate to moderate to strong correlation between HRT CRT STS TRT FTT TUG 10MWT and 6MWT and the FES-I and will be used in in the follow-up study The MFS was excluded from the final test battery due to a lack of correlation with dependent variables Moreover the dependent variables assessed on the force plate HRT CRT STS TRT and FTT power and force were correlated with variables collected by performing the same test using only manual time Applying muscle strength and power data on the force plate was necessary to confirm internal consistency content and criterion validity as well as the degree to which the HRT CRT STS TRT and FTT test can be an adequate reflection of the same test data using only manual time variables as the final Friedrich-Baur Risk of Fall Index FBIndex should be conducted without the force plate using only time variables
This study decided to include more patients and more different neuromuscular diseases to assess a wider range of muscle weaknesses that can lead to falls Moreover the final test battery was defined and the standardised methodological procedure was established
Using regression and discrimination analysis the cross-sectional construct validity of a priori hypotheses Is there a multiple correlation between HRT CRT STS TRT FTT TUG 10MWT and 6MWT with FES-I will be tested
In the first part feasibility study of this project the following force plate tests were identified as suitable to assess muscle power force and balance variables Heel-Rise Test HRT Chair-Rise Test CRT Semi-tandem Stand STS Trunk-Rise Test TRT Foot-Tapping Test FTT They were used as predictors to assess patients muscle weakness and disability In addition to muscle power and force data collected on the force plate a second rater manually evaluated the time required to perform this test using a stopwatch Additionally three separate tests Timed Up and Go TUG 10-Meter-Walk Test 10MWT and 6-Minute-Walk Test 6MWT have been evaluated separately as standard care procedures The TUG 10MWT and 6MWT have been used to assess remaining motor skills endurance walking speed and coordination that cannot be covered by HRT CRT STS TRT and FTT As a third parameter used for correlation analysis two risk of fall scales Falls Efficacy Scale International FES-I and Morse Fall Scale MFS have been used The found data from the feasibility study which is planned to be published suggest a moderate to moderate to strong correlation between HRT CRT STS TRT FTT TUG 10MWT and 6MWT and the FES-I and will be used in in the follow-up study The MFS was excluded from the final test battery due to a lack of correlation with dependent variables Moreover the dependent variables assessed on the force plate HRT CRT STS TRT and FTT power and force were correlated with variables collected by performing the same test using only manual time Applying muscle strength and power data on the force plate was necessary to confirm internal consistency content and criterion validity as well as the degree to which the HRT CRT STS TRT and FTT test can be an adequate reflection of the same test data using only manual time variables as the final Friedrich-Baur Risk of Fall Index FBIndex should be conducted without the force plate using only time variables
This study decided to include more patients and more different neuromuscular diseases to assess a wider range of muscle weaknesses that can lead to falls Moreover the final test battery was defined and the standardised methodological procedure was established
Using regression and discrimination analysis the cross-sectional construct validity of a priori hypotheses Is there a multiple correlation between HRT CRT STS TRT FTT TUG 10MWT and 6MWT with FES-I will be tested
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None