Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04199975
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Patients with congenital or acquired upper limb structural abnormalities and peripheral nerve or brachial plexus palsies have significant loss of function. The use of orthoses may improve function particularly in performing specific tasks for which the orthoses are designed, depending on the patients' deficiencies and needs. The performance of orthoses may be enhanced by being light-weight, motor-driven, and ergonomic.

This pilot, prospective study is designed to test the feasibility and effectiveness of the specially designed orthoses.

Condition or Disease	Intervention/Treatment	Phase
Upper Limb Deformities, Congenital	Device: Orthoses	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
• Actual Study Start Date: Oct 4, 2019
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Orthoses Only one single arm in this study	Device: Orthoses; Power-Driven or Mechanical Orthoses

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale (VAS) Pain Score [Baseline]

   VAS pain score will be measured

2. Visual Analogue Scale (VAS) Pain Score [1-week after]

   VAS pain score will be measured

3. Short-Form Survey (SF-36) [Baseline]

   Generic health status instrument to assess quality of life

4. Short-Form Survey (SF-36) [1-week after]

   Generic health status instrument to assess quality of life

5. Active and passive range of motion (ROM) [Baseline]

   ROM will be measured to determine the joint stiffness

6. Active and passive range of motion (ROM) [1-week after]

   ROM will be measured to determine the joint stiffness

7. Disability of Arm, Shoulder and Hand (DASH) questionnaire [Baseline]

   Specially designed tool to assess upper extremity disability and symptoms

8. Disability of Arm, Shoulder and Hand (DASH) questionnaire [1-week after]

   Specially designed tool to assess upper extremity disability and symptoms

9. Patients' Satisfaction Score [Baseline]

   To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

10. Patients' Satisfaction Score [1-week after]

    To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

11. Grip Strength [Baseline]

    Will be measured in kg

12. Grip Strength [1-week after]

    Will be measured in kg

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with any congenital or acquired upper limb structural abnormalities

• Patients' condition is not suitable for surgical intervention or patients are not keen for surgical treatment

Exclusion Criteria:

• Patients have no available muscle signal input

• Patients fitted with a pacemaker or an implantable cardioverter defibrillator (ICD) or other implantable electrical devices

• Patients with contact dermatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Shatin		Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

• Principal Investigator: Chu Kay Michael Mak, FRCSEd(Orth), Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Chu Kay MAK, Associate Consultant and Clinical Assistant Professor (Honorary), Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04199975
• Other Study ID Numbers: Orthoses_Protocol_v1
• First Posted: Dec 16, 2019
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Limb Deformities, Congenital; Upper Extremity Deformities, Congenital

Study Results

No Results Posted as of Dec 16, 2019