Orthopedic ProceduresNCT06365710
Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture
A study testing Telerehabilitation and Traditional physiotherapy in people with Orthopedic Procedures and Physical Therapy Modalities, run by Töölö Hospital at 1 site in Finland.
Trial summary
Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture. Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care
- What is being tested?
- Telerehabilitation and Traditional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFinland
- Study dates
- 24 Nov 2022to 31 Jan 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fracture, which applies the surgical requirements
- age between 18 to 65 years
- Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
- No significant comorbidities
- No previous problems with the examined hand
- Ability to understand Finnish fluently
Who cannot join
- High energy or multiple injuries
- Open fractures
- Injury of both upper extremities
- Other operative injury on the same side
- Rheumatoid arthritis of other inflammatory joint disease
- Heavy smoker (over 20 cigarettes per day)
Show all 12Show fewer
- Disease of medication slowing ossification
- Alcohol or drug abuse
- Psychiatric disorder with poor treatment balance
- Neurological disorder which affects the function of the injured extremity
- Fixation material other than a volar locking plate
- Fracture fixation is not stable enough to start rehabilitation after 14 days
Trial locations and contacts
1 site in 1 country.
Turkka Anttila, M.D. contact
Finland1 site, 1 recruiting
- Recruiting
Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital
Helsinki, Uusimaa, 00029
Samuli Aspinen, M.D., Ph.D., +358406360546, samuli.aspinen@hus.fi
About this study
Official title: A Randomized Controlled Trial Comparing Traditional Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture: a Study Protocol
Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.
Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).
- Conditions
- Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures
- Being tested
- Telerehabilitation, Traditional physiotherapy
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Telerehabilitation program
Traditional physiotherapyOther
Guided rehabilitation program with physiotherapist appointments
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | The telerehabilitation group will start the physiotherapy guided by the digital care pathway postoperatively. The pathway includes videos, photos, animations and written material for rehabilitation of the operated hand. The same weightbearing instructions and mobilization exercises are shown in the videos and photos as are instructed in the physiotherapist appointment in the traditional physiotherapy group. Receives: Other: Telerehabilitation |
| Traditional Physiotherapy | Active comparator | The traditional physiotherapy group will attend appointment with the physiotherapist at two-week and five week timepoints. After this, this group can attend additional physiotherapist appointments if seen necessary by the physiotherapist or the surgeon. Receives: Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Wrist Evaluation (PRWE)
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
Measured: 12 months
Secondary outcomes (8)
Grip strength
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
Measured: 12 months
Quick Disabilities of the arm, shoulder, and hand
The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)
Measured: 12 months
Pain (Visual Analogue Scale)
The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).
Measured: 12 months
Wrist range of motion (ROM)
Wrist ROM is measured on both wrists with a handheld goniometer in degrees.
Measured: 12 months
Adverse events
Incidence of adverse events (i.e. non-union, fracture, reoperation, infection, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome, traumatic arthritis) is recorded and compared between study groups.
Measured: 12 months
Global improvement
Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
Measured: 12 months
Patient-rated Quality of Life (EQ-5D)
EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The options are in 5-step scale. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: 12 months
Cost-utility analysis
Quality-adjusted life years/months measured as a change in EQ-5D
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start24 Nov 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProceduresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuli Aspinen, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365710
- Sponsor's protocol ID
- HUS/206/2022
- Status last verified
- Oct 2024
- First submitted
- 9 Apr 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public access to the final trial dataset will be available on reasonable request from the principal investigator for research purposes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Traditional Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture: a Study Protocol
- ClinicalTrials.gov ID
- NCT06365710
- Acronym / sponsor ID
- HUS/206/2022
- Conditions
- Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 15 Apr 2024 (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.
Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.
Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: TelerehabilitationThe telerehabilitation group will start the physiotherapy guided by the digital care pathway postoperatively. The pathway includes videos, photos, animations and written material for rehabilitation of the operated hand. The same weightbearing instructions and mobilization exercises are shown in the videos and photos as are instructed in the physiotherapist appointment in the traditional physiotherapy group. |
| Traditional Physiotherapy | Active comparator | Other: Traditional physiotherapyThe traditional physiotherapy group will attend appointment with the physiotherapist at two-week and five week timepoints. After this, this group can attend additional physiotherapist appointments if seen necessary by the physiotherapist or the surgeon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Distal radius fracture, which applies the surgical requirements
- age between 18 to 65 years
- Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
- No significant comorbidities
- No previous problems with the examined hand
Key exclusion criteria (12 listed)
- High energy or multiple injuries
- Open fractures
- Injury of both upper extremities
- Other operative injury on the same side
- Rheumatoid arthritis of other inflammatory joint disease
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 |
|---|---|---|
| TelerehabilitationTelerehabilitation program | Other | Telerehabilitation |
| Traditional physiotherapyGuided rehabilitation program with physiotherapist appointments | Other | Traditional Physiotherapy |
Primary outcome
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
8 secondary outcomes
Grip strength
Time frame: 12 months
Quick Disabilities of the arm, shoulder, and hand
Time frame: 12 months
Pain (Visual Analogue Scale)
Time frame: 12 months
Wrist range of motion (ROM)
Time frame: 12 months
Adverse events
Time frame: 12 months
Global improvement
Time frame: 12 months
Patient-rated Quality of Life (EQ-5D)
Time frame: 12 months
Cost-utility analysis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. Public access to the final trial dataset will be available on reasonable request from the principal investigator for research purposes
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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.
Turkka Anttila, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Traditional physiotherapy in people with Orthopedic Procedures and Physical Therapy Modalities, run by Töölö Hospital at 1 site in Finland.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Oct 2024. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuli Aspinen, M.D.,Ph.D. (+358406360546, samuli.aspinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (PRWE) (time frame: 12 months). 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 31 Oct 2024.