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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496337
Other study ID # 634805
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date September 1, 2018

Study information

Verified date February 2018
Source Central Jutland Regional Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Other:
Assessment of motor and process skills test
At baseline and follow-up (after 8-10 weeks) all patients are assessed with AMPS in addition to the standard test of Canadian Occupational Performance Measure (COPM) hand grip strength and joint range of motion.

Locations

Country Name City State
Denmark Diagnostic Centre, Regional Hospital Silkeborg Silkeborg

Sponsors (1)

Lead Sponsor Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in "Assessment of motor and process skills (AMPS)" from baseline to 8 weeks The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. After an initial interview with the patient, the rater selects a subset of 3-5 ADL tasks from a list of standardized tasks that are described in the AMPS manual (e.g. fetching a drink from the fridge, folding laundry, preparing a sandwich). The tasks selected must be relevant and meaningful to the patient, and consist of tasks that he/she once knew how to perform. The tasks must be challenging to the patient. From this subset of tasks, the client then selects 2-3 tasks to perform. Measured at baseline and 8 weeks after baseline
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