COA At-a-Glance
Evidence of cognitive interviewing of draft instrument in target patient population
Evidence of internal consistency
Evidence of test-retest or inter-rater reliability
Evidence of concurrent validity
Evidence of known-groups validity
Evidence of ability to detect change over time
Evidence of responder thresholds
Inclusion of the COA in product labelling
- Overview
- Content Validity
- Reliability
- Validity
- Responder Thresholds
- Reference(s) of development / validation
- Other references
- Inclusion of the COA in product labelling
- Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
- Existence of Scoring / Interpretation / User Manual
- Original language and translations
- References of translations
- Authors and contact information
- Condition of use: copyright
- Website
- Review copy
Overview
Instrument Name: Timed Up and Go Test (TUG)
Abbreviation: TUG
Description of Tool:
The Timed Up and Go Test (TUG) is a ClinRO developed to assess mobility, balance, walking ability, and fall risk in older adults aged 52-94 years. The TUG has been used to assess functional mobility in the pediatric population.
Minimum Qualification Required by COA Administrator: MA or BA
Year: 1986
Objective of Development:
To assess mobility, balance, walking ability, and fall risk in older adults
Population of Development: Age range (therapeutic indication):
52-94 years (All therapeutic indications)
Pediatric Population(s) in which COA has been used:
Respiratory Tract Diseases ; Immune System Diseases ; Musculoskeletal Diseases ; Neoplasms ; Hemic and Lymphatic Diseases ; Nervous System Diseases ; Pathological Conditions, Signs and Symptoms ; Eye Diseases ; OtorhiNolaryngologic Diseases ; Congenital, Hereditary, and Neonatal Diseases and Abnormalities ; Wounds and Injuries ; Male Urogenital Diseases ; Female Urogenital Diseases and Pregnancy Complications ; Nutritional and Metabolic Diseases ; Skin and Connective Tissue Diseases ; Mental Disorders ; Cardiovascular Diseases ; Endocrine System Diseases ; Respiratory Tract Diseases ; Digestive System Diseases
COA type: ClinRO
Number of Items 1 task
Mode of Administration: Clinician-rated
Data Collection Mode: Paper and pen
Time for Completion: Not reported
Response Scales: Time to accomplish the task (in seconds)
Summary of Scoring:
Available scores:
Global score is the total time (seconds)
Weighting:
No
Score Interpretation: Longer times = Higher risk of falling
Content Validity
Evidence of Literature Review: None identified
Evidence of Instrument Review: None identified
Evidence of Clinical or Expert Input: None identified
Evidence of concept elicitation in target patient population: None identified
Evidence of a Saturation Grid: None identified
Evidence for Selection of Data Collection Method: None identified
Recall/Observation Period: Present time
Evidence for Selection of Reponse Options: None identified
Evidence of cognitive interviewing of draft instrument in target patient population: None identified
Evidence of Preliminary Scoring of Items and Domains: None identified
Evidence related to respondent and administrator burden: None identified
Evidence of a Conceptual Framework: None identified
Evidence of an item-tracking matrix: None identified
Evidence related to item selection: None identified
Evidence of re-testing the final version: None identified
Reliability
Internal consistency (Cronbach's alpha): Not applicable
Evidence of internal consistency:
Test-retest Reliability (ICC):
Gocha Marchese (2003)
Intra-rater reliability
Intraclass Correlation Coefficient (ICC): 0.99
- Was a definition of stability applied to identify stable patients: No
- Time frame or interval between the two administrations: Not stated
- Population/Disease: Children with acute lymphoblastic
leukemia (ALL) and healthy controls (age range 4 to 15 years; median 9.6 years); n= 5
Inter-rater/ inter-interviewer reliability (kappa):
Mathias (1986) Inter-rater reliability: - Kendall's coefficient of concordance: p< 0.001 for all results Physiotherapists (n= 7): W= 0.85, df= 9 Senior doctors (n= 24): W= 0.686, df= 22 - Population/Disease: Elderly patients (age range 52-94 years); n= 40 Gocha Marchese (2003) Inter-rater reliability Intraclass Correlation Coefficient (ICC): 0.99 - Population/Disease: Children with acute lymphoblastic leukemia (ALL) and healthy controls (age range 4 to 15 years; median 9.6 years); n= 5
Evidence of test-retest or inter-rater reliability: Yes
Validity
Concurrent validity (convergent, divergent):
Dunaway S (2013)
1. Correlation coefficient used: Pearson's correlation coefficient
- Measure: 6-meter walk test (6MWT)
- Results: Significant correlation was found between 6MWD and TUG: r= -0.514; p= 0.050
- Population/Disease: Patients with SMA, n= 15; age included in the range 10 to 49 years
2. Correlation coefficient used: Pearson's correlation coefficient
- Measure: 10 meter wall/run
- Results: Significant correlation was found between TUG and the 10 meter walk/run: r= -0.717; p=0.003
- Population/Disease: Patients with SMA, n= 13; age included in the range 10 to 49 years
3. Correlation coefficient used: Pearson's correlation coefficient
- Measure: Manual Muscle Testing (MMT)
- Results:
Significant correlation was found between TUG and the MMT total score: r=-0.816; p<0.001
Significant correlation was found between TUG and the MMT upper score: r=-0.690; p=0.004
Significant correlation was found between TUG and MMT lower score: r= -0783; p<0.001
- Population/Disease: Patients with SMA, n= 15; age included in the range 10 to 49 years+Z21
4. Correlation coefficient used: Pearson's correlation coefficient
- Measure: hand-held dynamometry (HDD)
- Results:
Significant correlation was found between TUG and HHD knee flexor score: r=- 0.658; p=0.008
- Population/Disease: Patients with SMA, n= 15; age included in the range 10 to 49 years
Known-group validity:
Mathias (1986)
- Measure/Groups of patients: Gait measurements (Mean sway path; Gait speed; Step length; Stepping frequency; Double support/stride time)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Pearson correlation coefficient. There were significant correlations between the mean TUG score and the Mean sway path (r= 0.50; p< 0.001), Gait speed (r= -0.75; p< 0.001), Step length (r= 0.74; p< 0.001), Stepping frequency (r= -0.59; p< 0.001) and Double support/stride time (r= 0.52; p< 0.01)
- Population/Disease: Elderly patient (age range 52-94 years); n= 32-40
Gocha Marchese (2003)
KNown-groups validity
1 - Measure/Groups of patients: Children with acute lymphoblastic
leukemia (ALL)(n= 8) vs healthy controls (n= 8)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: T-test. At time zero, TUG means for children with ALL (5.44+ 1.26) were significantly greater than the mean for controls (4.00+0.81); t= 4.15, df= 7, p= 0.004
- Population/Disease: Children with ALL and healthy controls (age range 4 to 15 years; median 9.6 years); n= 16
2 - Measure/Groups of patients: Knee extension strength as measured by a Nicolas hand-held dynamometer
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Pearson correlation coefficient. A correlation of -0.794 (p= 0.05) was found between knee extension strength and TUG score for children with ALL. Children with ALL who had higher scores for knee extension strength performed the TUG task faster.
- Population/Disease: Children with ALL (age range 4 to 15 years; median 9.6 years); n= 8
Dunaway (2013)
- Measure/Groups of patients: Hammersmith Functional Motor Scale Expanded (HFMSE)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Pearson's coefficient correlation
Significant (p= 0.003) correlation was found between TUG and HFMSE: r= -0.717
- Population/Disease: Patients with SMA, n= 15; age included in the range 10 to 49 years
Evidence of Translatability Assessment: None identified
Evidence related to missing data: None identified
Evidence for Selection of Recall Period: None identified
Evidence of Administration Instructions and Training Provided: None identified
Evidence of concurrent validity: Yes
Evidence of known-groups validity: Yes
Evidence of ability to detect change over time: None identified
Responder Thresholds
Evidence of responder thresholds: None identified
Reference(s) of development / validation
Mathias S, Nayak US, Isaacs B. Balance in elderly patients: the "get-up and go" test. Arch Phys Med Rehabil. 1986 Jun;67(6):387-9
Other references
Gocha Marchese V, Chiarello LA, Lange BJ. Strength and functional mobility in children with acute lymphoblastic leukemia. Med Pediatr Oncol. 2003 Apr;40(4):230-2
Abstract: https://pubmed.ncbi.nlm.nih.gov/12555250/
Inclusion of the COA in product labelling
Yes
Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
Fampyra, Fampridine (EMA, 2011)
Results:
Published in the label/SPC: 22-May-2017
In this study there was a statistically significant treatment difference, with a greater proportion of Fampyra treated patients demonstrating an improvement in walking ability, compared to placebo-controlled patients (relative risk of 1.38 (95% CI: [1.06, 1.70]). Improvements generally appeared within 2 to 4 weeks of initiation of treatment, and disappeared within 2 weeks of treatment cessation.
Fampyra treated patients also demonstrated a statistically significant improvement in the Timed Up and Go (TUG) test, a measure of static and dynamic balance and physical mobility. In this secondary endpoint, a greater proportion of Fampyra treated patients achieved ≥ 15% mean improvement from baseline TUG speed over a 24 week period, compared to placebo. The difference in the Berg Balance Scale (BBS; a measure of static balance), was Not statistically significant.
In addition, patients treated with Fampyra demonstrated a statistically significant mean improvement from baseline compared to placebo in the Multiple Sclerosis Impact Scale (MSIS-29) physical score (LSM difference -3.31, p<0.001).
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf
Existence of Scoring / Interpretation / User Manual
Yes
Original language and translations
Original: English
Translations:
None identified
References of translations
N/A
Condition of use: copyright
Copyright:
Public domain
CoU:
*Free access
*Other: please cite the original reference "Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8"
Website
Not reported
Review copy
None identified