Tele-rehabilitationtele-rehabNCT06232824
Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction
A study testing Tele-rehabilitation in people with Tele-rehabilitation and Anterior Cruciate Ligament Reconstruction, run by Kexin Wang, MM.
Trial summary
The investigators aims to evaluate the effect of multicomponent supervised tele-rehabilitation, compared to home-based self-rehabilitation, on range of motion (ROM), pain, muscle strength, and function in patients following ACLR. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tele-rehabilitation, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Tele-rehabilitation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 50 years at the time of recruit;
- BMI between 16 and 28 kg/m²;
- acute unilateral ACL rupture;
- plan for an ACLR surgery (with autologous hamstrings tendon reconstruction) under arthroscopy;
- ACL rupture to ACLR within 3 months;
- Patients can independently use mobile software and WeChat mini programs, and can operate related software through the "Huajiantong" mini program under the guidance of staff;
Who cannot join
- With synthetic tendon reconstruction;
- Concomitant meniscus lesion which needs operation;
- Concomitant other ligaments injury which needs operation;
- Concomitant intra-articular knee fracture;
- Concomitant fracture or injury which may affect postoperative exercise;
- Previous history of knee infection, fracture, and surgery;
Show all 10Show fewer
- Participate in knee exercises and/or rehabilitation programs in the past three months;
- Living outside the city, regular return to the hospital for follow-up cannot be guaranteed;
- Serious cardiopulmonary disease and unable to participate in rehabilitation exercise;
- Other reasons for exclusion (mental disorders, stroke, pregnancy, etc).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction
The investigators aims to evaluate the effect of multicomponent supervised tele-rehabilitation, compared to home-based self-rehabilitation, on range of motion (ROM), pain, muscle strength, and function in patients following ACLR. The hypothesis is of superiority for the effects of multicomponent supervised tele-rehabilitation over home-based self-rehabilitation.
- Being tested
- Tele-rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitationBehavioural
The whole program is constituted of preoperative education and postoperative rehabilitation (in hospital and out of hospital). All the participants received the same preoperative education through the mobile phone application and oral communication. Participants in the intervention group get the multicomponent supervised tele-rehabilitation, while participants in the control group get the home-based self-rehabilitation. All the postoperative rehabilitation programs are presented and executed through the mobile phone application.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment.
Participants in the intervention group received detailed education and rehabilitation program on the mobile phone application including text, photos, and videos. On the first day of enrollment, the doctor inform the participants of the importance of rehabilitation and how to use the mobile phone application. The postoperative rehabilitation protocol includes four phases: Phase 1 (0-2 weeks), Phase 2 (3-4 weeks), Phase 3 (5-8 weeks), Phase 4 (9-12 weeks), and Phase 5 (after 13 weeks). Receives: Behavioral: Tele-rehabilitation |
| Control | No intervention | Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively. At the 2, 4, 8, 12, and 24 weeks after ACLR, all participants went to the outpatient clinic for follow-up by physiotherapist to provide face-to-face guidance for exercise methods. Physiotherapist would clarify the content of the rehabilitation plan if any doubt, but will not provide information extending the prearranged scope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
In the first 3 months after ACLR, the achievement of acceptable knee active extension and flexion was regarded as what matters most for a successful recovery. A good knee active ROM could guarantee an expectedly continue improvement.
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Secondary outcomes (7)
active and passive ROM
The active and passive ROM of the affected side knee
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Visual analogue scale (VAS)
The postoperative pain was measured with VAS. The VAS scale ranges from 0 to 10 points, 0 points represent no pain, while 10 points represent the worst imaginable pain. A higher VAS score mean a worse outcome.
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Muscle strength
The isokinetic concentric strength test was used to assess muscle strength. Isokinetic concentric extenso was the best rated with sufficient intrarater reliability and construct validity for the measurement of knee muscle strength
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
The 2000 International Knee Documentation Committee (IKDC)
The 2000 International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities. Scores are obtained by summing the individual items and then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
knee injury and osteoarthritis outcome score (KOOS)
The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
the Tegner activity scale
the Tegner activity scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes.
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
the Lysholm knee scoring scale
The Lysholm Knee Score is a questionnaire consisting of 8 items that the patient completes together with the therapist. The questionnaire is designed to assess the degree of knee instability at both impairment and limitation levels. .The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema.A higher score mean a better outcome. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Measured: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tele-rehabilitationStudies 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
- Model description
- Intervention Participants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment. Control Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kexin Wang, MM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kexin Wang, MM, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232824
- Sponsor's protocol ID
- WestChinaH20240116
- Acronym
- tele-rehab
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang K, Peng L, You M, Deng Q, Li J. Multicomponent supervised tele-rehabilitation versus home-based self-rehabilitation management after anterior cruciate ligament reconstruction: a study protocol for a randomized controlled trial. J Orthop Surg Res. 2024 Jun 28;19(1):381. doi: 10.1186/s13018-024-04871-0.
PubMed 38943178
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06232824
- Acronym / sponsor ID
- tele-rehab / WestChinaH20240116
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Kexin Wang, MMUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 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.
The investigators aims to evaluate the effect of multicomponent supervised tele-rehabilitation, compared to home-based self-rehabilitation, on range of motion (ROM), pain, muscle strength, and function in patients following ACLR. The hypothesis is of superiority for the effects of multicomponent supervised tele-rehabilitation over home-based self-rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Participants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment. Control Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Tele-rehabilitationParticipants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment. Participants in the intervention group received detailed education and rehabilitation program on the mobile phone application including text, photos, and videos. On the first day of enrollment, the doctor inform the participants of the importance of rehabilitation and how to use the mobile phone application. The postoperative rehabilitation protocol includes four phases: Phase 1 (0-2 weeks), Phase 2 (3-4 weeks), Phase 3 (5-8 weeks), Phase 4 (9-12 weeks), and Phase 5 (after 13 weeks). |
| Control | No intervention | –Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively. At the 2, 4, 8, 12, and 24 weeks after ACLR, all participants went to the outpatient clinic for follow-up by physiotherapist to provide face-to-face guidance for exercise methods. Physiotherapist would clarify the content of the rehabilitation plan if any doubt, but will not provide information extending the prearranged scope. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 50 years at the time of recruit;
- BMI between 16 and 28 kg/m²;
- acute unilateral ACL rupture;
- plan for an ACLR surgery (with autologous hamstrings tendon reconstruction) under arthroscopy;
- ACL rupture to ACLR within 3 months;
Key exclusion criteria (10 listed)
- With synthetic tendon reconstruction;
- Concomitant meniscus lesion which needs operation;
- Concomitant other ligaments injury which needs operation;
- Concomitant intra-articular knee fracture;
- Concomitant fracture or injury which may affect postoperative exercise;
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 |
|---|---|---|
| Tele-rehabilitationThe whole program is constituted of preoperative education and postoperative rehabilitation (in hospital and out of hospital). All the participants received the same preoperative education through the mobile phone application and oral communication. Participants in the intervention group get the multicomponent supervised tele-rehabilitation, while participants in the control group get the home-based self-rehabilitation. All the postoperative rehabilitation programs are presented and executed through the mobile phone application. | Behavioural | Intervention |
Primary outcome
the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
In the first 3 months after ACLR, the achievement of acceptable knee active extension and flexion was regarded as what matters most for a successful recovery. A good knee active ROM could guarantee an expectedly continue improvement.
7 secondary outcomes
active and passive ROM
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Visual analogue scale (VAS)
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Muscle strength
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
The 2000 International Knee Documentation Committee (IKDC)
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
knee injury and osteoarthritis outcome score (KOOS)
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
the Tegner activity scale
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
the Lysholm knee scoring scale
Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 38943178Wang K, Peng L, You M, Deng Q, Li J. Multicomponent supervised tele-rehabilitation versus home-based self-rehabilitation management after anterior cruciate ligament reconstruction: a study protocol for a randomized controlled trial. J Orthop Surg Res. 2024 Jun 28;19(1):381. doi: 10.1186/s13018-024-04871-0.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation in people with Tele-rehabilitation and Anterior Cruciate Ligament Reconstruction, run by Kexin Wang, MM.
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 10 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: opening soon, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kexin Wang, MM (+86 15881189695, wangkexin3@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients who achieve a satisfactory active ROM (flexion and extension) (time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232824, which also lists 1 linked publication.
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 Jan 2024.