Prospective multicentre validation study of a new standardized version of the 400 points hand assessment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN25874481

Enrollment

250

Registered

2019-02-07

Start date

2013-05-01

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand injuries Injury, Occupational Diseases, Poisoning Injuries to the wrist and hand

Interventions

Data at admission: patients were screened for inclusion and exclusion criteria and received an information sheet. Patients who fulfilled inclusion criteria and willing to participate signed an informe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over 18 years hospitalized or not with: 1. Unilateral traumatic hand impairment (fractures, tendons lesions, wounds, peripheral traumatic neuropathy) 2. Complex Regional Pain Syndrome (CRPS)

Exclusion criteria

Exclusion criteria: 1. Patients aged under 18 years 2. Bilateral hand impairment 3. Central neurological impairment 4. Severe psychiatric disorders 5. Patients unable to fulfilled the questionnaires or to understand the instructions of 400 Points HA 6. Impossibility to plan the 400 Points HA at the entry 7. Contraindication for the 400 Points HA at the entry (recent surgery)

Design outcomes

Primary

Measure	Time frame
Criterion validity assessed with Spearman’s correlation coefficients (r) between 400 points HA and JTHFT at T0	—

Secondary

Measure	Time frame
T0= first test , T and T2= 1 to 4 days after T0, T3= 3 to 4 weeks after T0 1. Construct validity assessed with Pearson's correlations coefficients between 400 points HA and QuickDASH, MOS SF36 physical component and mental component and pain at T0 2. Internal consistency assessed with Cronbach alpha of the 400 points HA for each test and for the total score at T0 3. Intra and inter evaluator reliability of the 400 points HA assessed with intraclass correlation coefficient (ICC) and Bland Altman method of the 400 points HA between T0 and T1 (intra) and T0 and T2 (inter) 4. Responsiveness assessed with: 4.1. Anchor based approach: calculation of the MCID with ROC method and mean change of scoreof the 400 points HA and the QuickDASH between T0 and T3 4.2. Distribution based approach: calculation of the standard error of measurement (SEM), mimimun detectable change (MDC), effect size (ES), standardized response mean (SRM) for 400 points AH and QuickDASH, between T0 and T3	—

Measure

Time frame

T0= first test , T and T2= 1 to 4 days after T0, T3= 3 to 4 weeks after T0 1. Construct validity assessed with Pearson's correlations coefficients between 400 points HA and QuickDASH, MOS SF36 physical component and mental component and pain at T0 2. Internal consistency assessed with Cronbach alpha of the 400 points HA for each test and for the total score at T0 3. Intra and inter evaluator reliability of the 400 points HA assessed with intraclass correlation coefficient (ICC) and Bland Altman method of the 400 points HA between T0 and T1 (intra) and T0 and T2 (inter) 4. Responsiveness assessed with: 4.1. Anchor based approach: calculation of the MCID with ROC method and mean change of scoreof the 400 points HA and the QuickDASH between T0 and T3 4.2. Distribution based approach: calculation of the standard error of measurement (SEM), mimimun detectable change (MDC), effect size (ES), standardized response mean (SRM) for 400 points AH and QuickDASH, between T0 and T3

—

Countries

France, Portugal, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026