Hand Injury Patients Receiving Different Rehabilitation Programs

NCT02465840 | Completed

• 1 other identifier: CMRPG8D0931
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hand injury is one of common occupational or traumatic injury at outpatient clinic of rehabilitation department. The motor or sensory deficits after hand trauma including bony fracture,tendon / nerve injury, joint stiffness, motion restriction, sensory impairment, or pain lead to impaired upper extremity function, ability for daily activity, or quality of life. Rehabilitation is a kind of therapy for disability after hand trauma. It could provide pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma. The investigators consider that there are some deficits in hand function and range of motion, pain after injury, and some attenuation of brain functional MRI (fMRI) for hand motor control. Therefore, optimal and early intervention of rehabilitation programs may have some benefits for their hand functional outcome and improve the brain activities in fMRI images for the hand motor control. The aims of this study are to compare the differences in hand motor control area of brain functional MRI (fMRI) between normal subjects and hand injury patients before treatment and to investigate the improvement in brain fMRI activity and functional outcome after early rehabilitation in hand injury patients. The investigators will collect 40 patients with hand trauma after operation and 10 normal subjects in this study. The 10 normal subjects were allocated in the control group. These 40 patients were randomly divided into 2 experimental groups: 20 patients in group A and 20 patients in group B. In group A and B, the patients will perform immobilization and Kleinert programs respectively. All patients will perform rehabilitation regimen with 2-3 sessions per week for 3-6 months. Before and after rehabilitation, all patients will receive physical examinations, brain fMRI, and DASH questionnaire for daily activity.

Conditions

Hand Injury

Keywords

rehabilitation; functional MRI

Outcome Measures

Primary Outcomes (1)

• change from baseline in motor function

  QuickDASH quesrtionnaire for upper extremity

  baseline, three months and six months

Secondary Outcomes (4)

• Functional MRI

  baseline, three months and six months

• wrist pain

  baseline, three months and six months

• wrist sensory

  baseline, three months and six months

• wrist range of motion

  baseline, three months and six months

Study Arms (2)

Immobilization programs

PLACEBO COMPARATOR

custom-made protective hand splint physical therapy and occupational therapy

Procedure: custom-made protective hand splint; Other: physical therapy and occupational therapy

Kleinert programs

EXPERIMENTAL

custom-made dynamic hand splint physical therapy and occupational therapy

Procedure: custom-made dynamic hand splint; Other: physical therapy and occupational therapy

Interventions

custom-made dynamic hand splint PROCEDURE

custom-made dynamic splinting with more early active exercises intervention.

Also known as: Dynamic splint

Kleinert programs

custom-made protective hand splint PROCEDURE

Immobilization splint with gentle ROM exercises

Also known as: resting hand splint

Immobilization programs

physical therapy and occupational therapy OTHER

both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.

Immobilization programs; Kleinert programs

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients have a hand trauma injury after operation (\< 3 months)

You may not qualify if:

• previous history of hand injury
• infection disease; arthritis
• systemic neuromuscular disease
• single tendon injury.
• central nerve system disorder

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (26)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 4598164 BACKGROUND

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  PMID: 3331174 BACKGROUND

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  PMID: 12690845 BACKGROUND

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  PMID: 12015728 BACKGROUND

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  PMID: 12132086 BACKGROUND

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  BACKGROUND

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  PMID: 10194013 BACKGROUND

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  PMID: 12942228 BACKGROUND

• Tang JB, Wang B, Chen F, Pan CZ, Xie RG. Biomechanical evaluation of flexor tendon repair techniques. Clin Orthop Relat Res. 2001 May;(386):252-9. doi: 10.1097/00003086-200105000-00033.

  PMID: 11347844 BACKGROUND

• Sirotakova M, Elliot D. Early active mobilization of primary repairs of the flexor pollicis longus tendon with two Kessler two-strand core sutures and a strengthened circumferential suture. J Hand Surg Br. 2004 Dec;29(6):531-5. doi: 10.1016/j.jhsb.2004.07.002.

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MeSH Terms

Conditions

Hand Injuries

Interventions

Splints; Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Huang Yu Chi, Bachelor

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: June 9, 2015
• Study Start: August 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 24, 2018

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share