NCT03496337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 21, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

February 6, 2018

Last Update Submit

December 20, 2018

Conditions

Keywords

activities of daily livingassessment of motor and process skillsvalidation studyresponsiveness study

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostic Centre, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Radius FracturesHand Injuries

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Nanna Rolving, PhD

    Regionshospitalet Silkeborg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

April 12, 2018

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

December 21, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations