Clinical trial NCT03496337: Is AMPS a Responsive Tool for Assessing Change in ADL-abilities After Finger or Hand Surgery
Official title: Is AMPS a Responsive Tool for Assessing Change in ADL-abilities in Patients Undergoing Rehabilitation After Finger or Hand Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radius Fractures
Hand Fracture
Hand Injuries
Keywords: activities of daily living
assessment of motor and process skills
validation study
responsiveness study
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are included from the department of physical and occupational therapy at Silkeborg Regional Hospital in the period November 2017 to May 2018. A total of 50 patients, who have been referred for specialized occupational therapy rehabilitation following finger, hand, wrist or forearm surgery, will be included.

Brief summary: The aim of the study is to assess the responsiveness of the Assessment of Motor and Process Skills (AMPS) in a population of patients undergoing rehabilitation following hand surgery, as this has not previously been investigated.

Methods: Patients are included from the department of physical and occupational therapy at Silkeborg Regional Hospital in the period November 2017 to May 2018. A total of 50 patients, who have been referred for specialized occupational therapy rehabilitation following finger or hand surgery, will be included. At baseline and follow-up (after 8 weeks) all patients are assessed with AMPS, Canadian Occupational Performance Measure (COPM), hand grip strength and joint range of motion using standardized methods. Responsiveness to change is evaluated using an anchor-based method, comparing AMPS scores with the scores on the Global Rating Scale. The area under the ROC curve will be calculated, and an area under the curve of 0.7 is considered acceptable. Convergent and discriminative validity of the AMPS will be assessed across the different instruments used. Thus the investigators expect a higher correlation between AMPS and COPM and lower correlation between AMPS and hand grip strength and range of motion.

Detailed description: Rehabilitation following finger or hand surgery is often evaluated using only instruments assessing bodily function, e.g. hand grip strength and joint range of motion. However, considering the ICF rehabilitation framework, outcome measures should focus more on activity and participation. Furthermore, many patients requiring finger or hand surgery are still at the labor market, which underlines the importance of a valid assessment of their abilities in terms of activity and participation. This study will provide valuable knowledge in terms of whether AMPS is a valid tool for measuring improvement on these parameters in a population for which AMPS has not traditionally been used.

The aim of the study is to assess the responsiveness of the Assessment of Motor and Process Skills (AMPS) in a population of patients undergoing rehabilitation following hand surgery, as this has not previously been investigated.

Methods: Patients are included from the department of physical and occupational therapy at Silkeborg Regional Hospital in the period November 2017 to July 2018. A total of 50 patients, who have been referred for specialized occupational therapy rehabilitation following finger or hand injuries, will be included. Patients are excluded if they have movement restrictions following surgery (e.g. following surgery for tendon ruptures).

At baseline and follow-up (after 8 weeks) all patients are assessed with AMPS, Canadian Occupational Performance Measure (COPM), hand grip strength and joint range of motion using standardized methods. All test procedures are performed according to a standardized test protocol.

Statistical methods: Responsiveness to change is evaluated using an anchor-based method, comparing AMPS scores with the scores on the Global Rating Scale. The area under the ROC curve will be calculated, and an area under the curve of 0.7 is considered acceptable. Convergent and discriminative validity of the AMPS will be assessed across the different instruments used. Thus a higher correlation between AMPS and COPM and lower correlation between AMPS and hand grip strength and range of motion is expected.

Eligibility criteria: Inclusion Criteria:

* Patients referred for occupational therapy rehabilitation at Silkeborg Regional Hospital following surgery of the forearm, wrist, hand or fingers.

Exclusion Criteria:

* Patients who cannot perform rehabilitation due to movement restrictions following surgery.

Primary outcomes:
measure: Change in "Assessment of motor and process skills (AMPS)" from baseline to 8 weeks
timeFrame: Measured at baseline and 8 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Diagnostic Centre, Regional Hospital Silkeborg
Study officials:
affiliation: Regionshospitalet Silkeborg
name: Nanna Rolving, PhD
role: PRINCIPAL_INVESTIGATOR
References: