## Protocol Section
### Identification Module
**NCT ID:** NCT06432946

**Brief Title:** Sensing-glove System in Manual Therapy

**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

#### Organization Study ID Info
**ID:** UQTR_IP_Acceptabilite_2021
#### Organization
**Class:** OTHER
**Full Name:** Université du Québec à Trois-Rivières
### Status Module
#### Completion Date
**Date:** 2021-08-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Université du Québec à Trois-Rivières

#### Responsible Party

**Investigator Affiliation:** Université du Québec à Trois-Rivières

**Investigator Full Name:** Isabelle Pagé

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Spinal Manipulation

**Keywords:**

- Chiropractic

- Manual therapy

- Acceptability

- Usability

- Force-time characteristics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Participants will undergo two interventions consecutively, with the order of evaluation randomized.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Video

- Other: Practice session

**Label:** Video followed by practice

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Video

- Other: Practice session

**Label:** Practice followed by video

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Practice followed by video

- Video followed by practice

**Description:** 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.

**Name:** Video

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Practice followed by video

- Video followed by practice

**Description:** 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.

**Name:** Practice session

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** French version of the questionnaire based on the extended version of the Unified Theory of Acceptance and Use of Technology (UTAUT2)

**Measure:** Acceptability

**Time Frame:** Immediately following each intervention and at baseline

**Description:** French version of the System usability scale (F-SUS).

**Measure:** Usability

**Time Frame:** Immediately following each intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Being a licensed chiropractor or a last-year intern in a University outpatient chiropractic clinic

Exclusion Criteria:

* Reported any upper limb injury preventing them from executing manual therapies during the time of the study
* Previous experience with the sensing-glove system

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Trois-Rivières

**Country:** Canada

**Facility:** Université du Québec à Trois-Rivières

**State:** Quebec

**Zip:** G8Z 4M3

#### Overall Officials

**Official 1:**

**Affiliation:** Université du Québec à Trois-Rivières

**Name:** Isabelle Pagé, DC, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
