Spinal ManipulationNCT06432946
Sensing-glove System in Manual Therapy
A study testing Video and Practice session in people with Spinal Manipulation, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spinal Manipulation
- What is being tested?
- Video and Practice session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 31 Aug 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a licensed chiropractor or a last-year intern in a University outpatient chiropractic clinic
Who cannot join
- Reported any upper limb injury preventing them from executing manual therapies during the time of the study
- Previous experience with the sensing-glove system
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3
About this study
Official title: Effect of Two Facilitating Interventions on the Acceptability and Usability Towards a Sensing-glove System to Measure Force-time Characteristics of Spinal Manipulative Therapy: a Mixed-methods Cross-over Study
The objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. The primary questions it aims to address are:
- Are manual therapists receptive to employing a sensing-glove system to measure the force applied during spinal manipulations on patients?
- Can we enhance manual therapists' attitudes towards this system through either a brief informational video demonstration or a supervised practice session with the system?
Read more
Researchers will compare the impact of a 7-minute informational video to that of a 20-minute supervised practice session to determine if manual therapists' attitudes towards the use of a sensing-glove while treating their patients can be positively influenced.
Participants will:
- Engage in a single experimental session.
- Complete a questionnaire at the beginning of the experimental session.
- Undergo one of the two interventions and promptly complete two questionnaires following this intervention.
- Undergo the other intervention and promptly complete the same two questionnaires following this intervention.
Read the detailed description
This study aimed to evaluate manual therapists' acceptability of a sensing-glove system for measuring spinal manipulation's force-time characteristics and compare the effectiveness of two interventions in enhancing their acceptability and usability perception. Participants will undergo two acceptability-enhancing interventions in randomized order: a 7-minute informational video and a 20-minute supervised practice session. At the start of the session and after each intervention, the acceptability and perception of usability towards the system will be assessed.
- Conditions
- Spinal Manipulation
- Being tested
- Video, Practice session
- Keywords
- Chiropractic, Manual therapy, Acceptability, Usability, Force-time characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
A 7-minute video demonstrating the sensing-glove system, how it can be used to assess manual therapy biomechanics, and its relevance in research and clinical contexts. The video was created by the research team via a voiceover PowerPoint presentation.
Practice sessionOther
A 20-minute practice session during which participants received verbal information about the sensing-glove system. While wearing the sensing glove, participants performed palpation and manual therapy techniques (palpation, spinal mobilization/manipulation to the cervical and thoracic spine) on a human-sized manikin, guided by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Video followed by practice | Experimental | Participants will initially view a 7-minute informational video followed by a 20-minute supervised practice session with the sensing-glove system. Acceptability and usability perception will be assessed after each intervention. Receives: Other: Video; Other: Practice session |
| Practice followed by video | Experimental | Participants will initially participate in a 20-minute supervised practice session with the sensing-glove system followed by viewing a 7-minute informational video. Acceptability and usability perception will be assessed after each intervention. Receives: Other: Video; Other: Practice session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
French version of the questionnaire based on the extended version of the Unified Theory of Acceptance and Use of Technology (UTAUT2). A higher score indicates a higher level of acceptability.
Measured: Immediately following each intervention and at baseline
Usability
French version of the System usability scale (F-SUS). A higher score indicates a higher level of usability.
Measured: Immediately following each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Jun 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal ManipulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will undergo two interventions consecutively, with the order of evaluation randomized.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Pagé, Université du Québec à Trois-Rivières
- Investigators
- Isabelle Pagé, DC, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432946
- Sponsor's protocol ID
- UQTR_IP_Acceptabilite_2021
- Status last verified
- Mar 2025
- First submitted
- 22 May 2024
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Facilitating Interventions on the Acceptability and Usability Towards a Sensing-glove System to Measure Force-time Characteristics of Spinal Manipulative Therapy: a Mixed-methods Cross-over Study
- ClinicalTrials.gov ID
- NCT06432946
- Acronym / sponsor ID
- UQTR_IP_Acceptabilite_2021
- Conditions
- Spinal Manipulation
- Keywords
- Chiropractic, Manual therapy, Acceptability, Usability, Force-time characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 May 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 objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. The primary questions it aims to address are:
- Are manual therapists receptive to employing a sensing-glove system to measure the force applied during spinal manipulations on patients?
- Can we enhance manual therapists' attitudes towards this system through either a brief informational video demonstration or a supervised practice session with the system?
Researchers will compare the impact of a 7-minute informational video to that of a 20-minute supervised practice session to determine if manual therapists' attitudes towards the use of a sensing-glove while treating their patients can be positively influenced.
Participants will:
- Engage in a single experimental session.
- Complete a questionnaire at the beginning of the experimental session.
- Undergo one of the two interventions and promptly complete two questionnaires following this intervention.
- Undergo the other intervention and promptly complete the same two questionnaires following this intervention.
Detailed description
This study aimed to evaluate manual therapists' acceptability of a sensing-glove system for measuring spinal manipulation's force-time characteristics and compare the effectiveness of two interventions in enhancing their acceptability and usability perception. Participants will undergo two acceptability-enhancing interventions in randomized order: a 7-minute informational video and a 20-minute supervised practice session. At the start of the session and after each intervention, the acceptability and perception of usability towards the system will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will undergo two interventions consecutively, with the order of evaluation randomized.
| Arm | Type | Receives |
|---|---|---|
| Video followed by practice | Experimental | Other: Video, Other: Practice sessionParticipants will initially view a 7-minute informational video followed by a 20-minute supervised practice session with the sensing-glove system. Acceptability and usability perception will be assessed after each intervention. |
| Practice followed by video | Experimental | Other: Video, Other: Practice sessionParticipants will initially participate in a 20-minute supervised practice session with the sensing-glove system followed by viewing a 7-minute informational video. Acceptability and usability perception will be assessed after each intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Being a licensed chiropractor or a last-year intern in a University outpatient chiropractic clinic
Key exclusion criteria (2 listed)
- Reported any upper limb injury preventing them from executing manual therapies during the time of the study
- Previous experience with the sensing-glove system
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 |
|---|---|---|
| VideoA 7-minute video demonstrating the sensing-glove system, how it can be used to assess manual therapy biomechanics, and its relevance in research and clinical contexts. The video was created by the research team via a voiceover PowerPoint presentation. | Other | Practice followed by video, Video followed by practice |
| Practice sessionA 20-minute practice session during which participants received verbal information about the sensing-glove system. While wearing the sensing glove, participants performed palpation and manual therapy techniques (palpation, spinal mobilization/manipulation to the cervical and thoracic spine) on a human-sized manikin, guided by the researcher. | Other | Practice followed by video, Video followed by practice |
Primary outcome
Acceptability
Time frame: Immediately following each intervention and at baseline
French version of the questionnaire based on the extended version of the Unified Theory of Acceptance and Use of Technology (UTAUT2). A higher score indicates a higher level of acceptability.
Usability
Time frame: Immediately following each intervention
French version of the System usability scale (F-SUS). A higher score indicates a higher level of usability.
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 30 Mar 2025.
- 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.
Isabelle Pagé, DC, PhD principal investigator
Université du Québec à Trois-Rivières
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Practice session in people with Spinal Manipulation, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 2 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 30 Mar 2025. 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 Canada. 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?
Acceptability (time frame: Immediately following each intervention and at baseline). The study lists 2 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 Mar 2025.