Upper Limb SurgeryNCT04691739
Teletherapy for Upper Extremity Fracture Rehabilitation (TELE-REHAB Study)
A study testing occupational therapy in people with Upper Limb Surgery and Occupational Therapy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). The investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Surgery, Occupational Therapy
- What is being tested?
- occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 13 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have had operative fixation of upper extremity fracture located between the humeral shaft and distal radius (inclusive) who are indicated for outpatient occupational therapy.
- Participants at least 18 years (≥ 18 years of age).
- English-speaking participants
Who cannot join
- Participants unable to consent
- Vulnerable populations including prisoners and marginally housed patients
- Additional traumatic conditions that may affect the ultimate-use pattern of the injured limb including traumatic brain injury, spinal cord injury, peripheral nerve injury, or associated soft tissue injury requiring specific postoperative activity modifications.
- Contralateral upper extremity injury that prevents participating in the standardized exercises.
- Initiation of occupational therapy (OT) during an inpatient hospital stay
- Pre-existing comorbidities that may interfere with communication or that may limit the use of standard telecommunications tools (sight/hearing impaired, speech impaired)
- Patients without a smart-phone or internet access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Teletherapy for Upper Extremity Fracture Rehabilitation, A Pilot Randomized Controlled Trial (TELE-REHAB Study)
Following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). The investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. The proposed study is a pilot randomized controlled trial (RCT) testing the feasibility of comparing in-person occupational therapy to teletherapy following operative fixation of upper extremity fracture. It is a single site, parallel-arm, randomized controlled trial to compare teletherapy versus in-person occupational therapy. Patients who are eligible will be randomized similar to a flip of a coin (1:1) to occupational therapy in-person or through a telemedicine platform. Patients would also complete surveys at each follow-up visit to measure clinical outcomes.
- Conditions
- Upper Limb Surgery, Occupational Therapy
- Being tested
- occupational therapy
- Keywords
- Upper Limb Surgery, Upper Extremity Injury, Occupational Therapy
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapyOther
occupational therapy sessions include a set of standardized test exercises plus additional modalities that are optimized to each patient's needs according to the clinical judgement of the treating therapist
| Study group | Role | What they receive |
|---|---|---|
| In-person occupational therapy | Active comparator | occupational therapy delivered in-person Receives: Other: occupational therapy |
| Teletherapy | Active comparator | Video-conferencing occupational therapy Receives: Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome 1: Enrollment rate
A success threshold of 40% enrollment of eligible patients
Measured: At 12 months
Feasibility outcome 2a: Completion rate
A success threshold of 90% patient follow-up and case report forms completion rates
Measured: at 6 weeks
Feasibility outcome 2b: Completion rate
A success threshold of 90% patient follow-up and case report forms
Measured: at 3 months
Feasibility outcome 2c: Completion rate
A success threshold of 90% patient follow-up and case report forms
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start10 Jan 2022
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Why it stopped: Study did not enroll participants that meet inclusion criteria outlined in the study protocol. All screening and enrollment attempts have ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb SurgeryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Langhammer, University of Maryland, Baltimore
- Investigators
- Christopher Langhammer, MD, Principal investigator, U of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691739
- Sponsor's protocol ID
- HP-00094373
- Status last verified
- Nov 2023
- First submitted
- 24 Dec 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teletherapy for Upper Extremity Fracture Rehabilitation, A Pilot Randomized Controlled Trial (TELE-REHAB Study)
- ClinicalTrials.gov ID
- NCT04691739
- Acronym / sponsor ID
- HP-00094373
- Conditions
- Upper Limb Surgery, Occupational Therapy
- Keywords
- Upper Limb Surgery, Upper Extremity Injury, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not enroll participants that meet inclusion criteria outlined in the study protocol. All screening and enrollment attempts have ended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 31 Dec 2020 (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.
Following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). The investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. The proposed study is a pilot randomized controlled trial (RCT) testing the feasibility of comparing in-person occupational therapy to teletherapy following operative fixation of upper extremity fracture. It is a single site, parallel-arm, randomized controlled trial to compare teletherapy versus in-person occupational therapy. Patients who are eligible will be randomized similar to a flip of a coin (1:1) to occupational therapy in-person or through a telemedicine platform. Patients would also complete surveys at each follow-up visit to measure clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person occupational therapy | Active comparator | Other: occupational therapyoccupational therapy delivered in-person |
| Teletherapy | Active comparator | Other: occupational therapyVideo-conferencing occupational therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have had operative fixation of upper extremity fracture located between the humeral shaft and distal radius (inclusive) who are indicated for outpatient occupational therapy.
- Participants at least 18 years (≥ 18 years of age).
- English-speaking participants
Key exclusion criteria (7 listed)
- Participants unable to consent
- Vulnerable populations including prisoners and marginally housed patients
- Additional traumatic conditions that may affect the ultimate-use pattern of the injured limb including traumatic brain injury, spinal cord injury, peripheral nerve injury, or associated soft tissue injury requiring specific postoperative activity modifications.
- Contralateral upper extremity injury that prevents participating in the standardized exercises.
- Initiation of occupational therapy (OT) during an inpatient hospital stay
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 |
|---|---|---|
| occupational therapyoccupational therapy sessions include a set of standardized test exercises plus additional modalities that are optimized to each patient's needs according to the clinical judgement of the treating therapist | Other | In-person occupational therapy, Teletherapy |
Primary outcome
Feasibility outcome 1: Enrollment rate
Time frame: At 12 months
A success threshold of 40% enrollment of eligible patients
Feasibility outcome 2a: Completion rate
Time frame: at 6 weeks
A success threshold of 90% patient follow-up and case report forms completion rates
Feasibility outcome 2b: Completion rate
Time frame: at 3 months
A success threshold of 90% patient follow-up and case report forms
Feasibility outcome 2c: Completion rate
Time frame: at 6 months
A success threshold of 90% patient follow-up and case report forms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- 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.
Christopher Langhammer, MD principal investigator
U of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy in people with Upper Limb Surgery and Occupational Therapy, run by University of Maryland, Baltimore at 1 site in United States.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Nov 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility outcome 1: Enrollment rate (time frame: At 12 months). The study lists 4 primary outcomes in all. 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 30 Nov 2023.