Radius FracturesNCT03496337
Is AMPS a Responsive Tool for Assessing Change in ADL-abilities After Finger or Hand Surgery
An observational study of Radius Fractures and Hand Fracture, run by Central Jutland Regional Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radius Fractures, Hand Fracture, Hand Injuries
- What is being tested?
- Assessment of motor and process skills test
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients referred for occupational therapy rehabilitation at Silkeborg Regional Hospital following surgery of the forearm, wrist, hand or fingers.
Who cannot join
- Patients who cannot perform rehabilitation due to movement restrictions following surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is AMPS a Responsive Tool for Assessing Change in ADL-abilities in Patients Undergoing Rehabilitation After Finger or Hand Surgery?
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.
Read the 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.
- Conditions
- Radius Fractures, Hand Fracture, Hand Injuries
- Being tested
- Assessment of motor and process skills test
- Keywords
- activities of daily living, assessment of motor and process skills, validation study, responsiveness study
- Medical subject headings
- Radius Fractures, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of motor and process skills testOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Nov 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanna Rolving, PhD, Principal investigator, Regionshospitalet Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496337
- Sponsor's protocol ID
- 634805
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is AMPS a Responsive Tool for Assessing Change in ADL-abilities in Patients Undergoing Rehabilitation After Finger or Hand Surgery?
- ClinicalTrials.gov ID
- NCT03496337
- Acronym / sponsor ID
- 634805
- Conditions
- Radius Fractures, Hand Fracture, Hand Injuries
- Keywords
- activities of daily living, assessment of motor and process skills, validation study, responsiveness study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients referred for occupational therapy rehabilitation at Silkeborg Regional Hospital following surgery of the forearm, wrist, hand or fingers.
Key exclusion criteria (1 listed)
- Patients who cannot perform rehabilitation due to movement restrictions following surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of motor and process skills testAt 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. | Other | – |
Primary outcome
Change in "Assessment of motor and process skills (AMPS)" from baseline to 8 weeks
Time frame: Measured at baseline and 8 weeks after baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanna Rolving, PhD principal investigator
Regionshospitalet Silkeborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radius Fractures and Hand Fracture, run by Central Jutland Regional Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "Assessment of motor and process skills (AMPS)" from baseline to 8 weeks (time frame: Measured at baseline and 8 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.