Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001644459
Ethics application status
Approved
Date submitted
29/03/2016
Date registered
28/11/2016
Date last updated
28/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimal Grasp Distance and Muscle Loads for People With Rheumatoid Arthritis Using Carpometacarpal and Metacarpophalangeal Immobilization Orthoses
Scientific title
Optimal Grasp Distance and Muscle Loads for People With Rheumatoid Arthritis Using Carpometacarpal and Metacarpophalangeal Immobilization Orthoses
Secondary ID [1] 288857 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 298152 0
Condition category
Condition code
Inflammatory and Immune System 298319 298319 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The carpometacarpal (CMC) and metacarpophalangeal (MP) immobilization orthosis was one short thumb immobilization orthosis that did not cover the thumb interphalangeal and wrist joints, and the orthosis was custom-molded by an occupational therapist with more than 6 years of experience. Participants wore the orthosis with their right hands for the duration of the testing procedure, approximately 30 minutes.

The grasp distance was the distance between the handle and the main shaft of the dynamometer. We designated the first, second, and third handle positions on the dynamometer as the grasp distances: Distance 1 (D1) was 42.25 mm, Distance 2 (D2) was 54.64 mm, and Distance 3 (D3) was 68.90 mm.

This study required only a single test session for each participant. Each participant performed three trials per condition for a total of 21 trials (maximal grip × 3 trials and 3 distances × 2 orthoses × 3 trials). The level of orthose factor was two: with or without orthosis. The order of the (distance × orthoses) conditions was randomly assigned. Rest periods of 1 minute were given between each trial, and periods of 5 minutes, between each condition. The participants could prolong the resting time if tired.

Grip Strength Measurement. Participants sat on a chair, and the seat height was adjusted so that their feet were flat on the floor with their knees and hips flexed at about 90 degrees. They then placed their right forearm on the table with the shoulder in adduction, the elbow at 60 degrees to 90 degrees flexion, the forearm in neutral position between pronation and supination, the wrist in neutral position between the ulnar and radial deviation, and the wrist at 10 degrees to 20 degrees extension,
and they concurrently grasped a Baseline digital hand dynamometer (Model 12-0112; Fabrication Enterprises, White Plains, NY). The values displayed by the dynamometer
were recorded. This participant positioning was adopted from Mathiowetz et al. (1985); however, the dynamometer was reversed to allow participants to see the readings. The forearm was placed on the table to help support the weight of the dynamometer.
Intervention code [1] 294326 0
Not applicable
Comparator / control treatment
Healthy participants will be used as a comparator to participants with rheumatoid arthritis; and Repeat testing procedure without any orthosis as a comparator to testing with each orthosis.
Control group
Active

Outcomes
Primary outcome [1] 297793 0
25%–35% of maximal grip, assessed using dynamometer.
Timepoint [1] 297793 0
The primary outcome is assessed at time of grip strength testing immediately following placement of each orthosis.
Secondary outcome [1] 322274 0
Muscle activation, assessed by surface EMG.
Timepoint [1] 322274 0
The surface EMG data is assessed simultaneously at time of grip strength testing.

Eligibility
Key inclusion criteria
The inclusion criteria for RA patients were (1) diagnosis of RA according to the 1987 American College of Rheumatology revised criteria (Arnett et al., 1988); (2) stable disease-modifying anti-rheumatic drug therapy within the preceding 6 months; (3) aged 20-80 years; (4) right-hand dominant; and (5) prescription of an immobilization orthosis by a doctor.

The inclusion criteria for non-RA patients were (1) aged 20-80 years; (2) right-hand dominant; (3) no history of right upper-extremity injury; and (4) normal functional performance of right upper-extremity.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of right upper-extremity injury

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
2x2 mixed analysis of variance (ANOVA) was used to analyze the maximal grip strength data and nEMG% data of each muscle for the group(2) x orthosis(2) experimental design. 2x3 repeated measure ANOVA was used to analyze the nEMG % data of each muscle for the orthosis(2) and grasp distance(3) experimental design. A least significant difference test was used as a follow-up test for pair-wise comparison of means. Significance was noted for a probability of a false positive of less than 5% (p < .05).

The clinical assumption of this study is patients with RA require more muscle loading to produce the same grip strength as healthy adults.

The statistical assumption is supported by the research of Hakkinen, Hakkinen, and Hakkinen (1995). In thier research, the mean grip strength of patients with RA were 58+/-17kg. The mean grip strength of healthy adults were 79+/-20kg.

We used G-Power 3.1.5 software to calculatte the sample size of our study. By the ANOVA: Repeated measures, between factors method, A priori test was performed. The effect size (f=0.5657111, tyep I error alpha =0.05, Power=0.8) were calculated by inputing the data of Hakkinen, Hakkinen, and Hakkinen (1995). The sample size advised by G-power software was 22 participants iin each groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2013
Date of last data collection
Anticipated
Actual
31/07/2013
Sample size
Target
22
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 7750 0
Taiwan, Province Of China
State/province [1] 7750 0
Taiwan

Funding & Sponsors
Funding source category [1] 293217 0
Hospital
Name [1] 293217 0
Catholic Cardinal Tien Hospital
Country [1] 293217 0
Taiwan, Province Of China
Funding source category [2] 294797 0
University
Name [2] 294797 0
Fu Jen Catholic University
Country [2] 294797 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Catholic Cardinal Tien Hospital
Address
No.362, Zhongzheng Rd., Xindian Dist., New Taipei City 23148
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292017 0
None
Name [1] 292017 0
Address [1] 292017 0
Country [1] 292017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294698 0
Cardinal Tien Hospital
Ethics committee address [1] 294698 0
Ethics committee country [1] 294698 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294698 0
01/03/2012
Approval date [1] 294698 0
01/07/2012
Ethics approval number [1] 294698 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64702 0
Prof Shih-Chen Fan
Address 64702 0
Department of Occupational Therapy,
I-Shou University
8 Eda Rd., Yanchao District, Kaohsiung City 82445
Country 64702 0
Taiwan, Province Of China
Phone 64702 0
+886, 7, 6151100#7502
Fax 64702 0
Email 64702 0
[email protected]
Contact person for public queries
Name 64703 0
Shih-Chen Fan
Address 64703 0
Department of Occupational Therapy,
I-Shou University
8 Eda Rd., Yanchao District, Kaohsiung City 82445
Country 64703 0
Taiwan, Province Of China
Phone 64703 0
+886, 7, 6151100#7502
Fax 64703 0
Email 64703 0
[email protected]
Contact person for scientific queries
Name 64704 0
Shih-Chen Fan
Address 64704 0
Department of Occupational Therapy,
I-Shou University
8 Eda Rd., Yanchao District, Kaohsiung City 82445
Country 64704 0
Taiwan, Province Of China
Phone 64704 0
+886, 7, 6151100#7502
Fax 64704 0
Email 64704 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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