Hand InjuryNCT02465840
Hand Injury Patients Receiving Different Rehabilitation Programs
A study testing custom-made dynamic hand splint, custom-made protective hand splint and physical therapy and occupational therapy in people with Hand Injury, run by Chang Gung Memorial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Hand Injury
- What is being tested?
- custom-made dynamic hand splint, custom-made protective hand splint and physical therapy and occupational therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 31 Dec 2017
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients have a hand trauma injury after operation (< 3 months)
Who cannot join
- previous history of hand injury
- infection disease; arthritis
- systemic neuromuscular disease
- single tendon injury.
- central nerve system disorder
About this study
Official title: The Functional Outcome and Brain Functional MRI of Hand Injury Patients After Different Rehabilitation Programs
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.
Read more
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.
Read the detailed description
Rehabilitation regimen is a noninvasive therapy for hand injured patients after operation. Protected active/passive motion is the mostly used method. Rehabilitation therapy could provide pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma. The investigators will collect 40 patients with hand trauma after operation and 10 normal subjects in this study. These 40 patients were divided into 2 experimental groups: 20 patients in group A ( immobilization program) and 20 patients in group B (Kleinert program).
A.The immobilization program 0-4 week: dorsal prospective splint in the wrist and MCP joint flexion and IP joint full extension.
3-4 weeks: Hourly: 10 repetitions of passive digital flexion and extension with wrist at 10ﾟextension. Hourly: 10 repetitions of active tendon gliding exercises.
4-6 weeks: dorsal blocking splint discontinued. Gentle blocking exercises initiated 10 repetitions, 4-6 times daily added to passive flexion and tendon gliding.
6-8 weeks: gentle resistive exercise being and progresses gradually. B.The Kleinert program 0-3 day: dorsal protective splint applied with wrist and MCP joints in flexion and IP joints in full extension; elastic traction from fingernail, through palmar pulley, to volar forearm. Velcro strap to allow night release of elastic traction, splinting IPs in full extension.
0-4 weeks: hourly active extension to limits of splint, followed by flexion with elastic traction only. Wound and scar management and education. 4-6 weeks: dorsal protective splint discontinued, sometimes replaced with wrist cuff and elastic traction. Night protective splint to prevent flexion contracture. Active wrist and gentle active fisting initiated unless signs of minimal adhesions. At 6 weeks blocking exercises begin.
6-8 weeks: progressive resistive exercises begin. The investigators will perform the physical examination, brain fMRI, and QuickDASH questionnaire for each patient before the program, 3 and 6 months later. Functional magnetic resonance imaging (fMRI) will be also performed in normal participants.
All patients will perform rehabilitation with 2-3 sessions per week. The investigators will perform the physical examination, brain fMRI, and QuickDASH questionnaire for each patient before the program, 3 and 6 months later. Functional magnetic resonance imaging (fMRI) will be also performed in normal participants.
- Conditions
- Hand Injury
- Being tested
- custom-made dynamic hand splint, custom-made protective hand splint, physical therapy and occupational therapy
- Keywords
- rehabilitation, functional MRI
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom-made dynamic hand splintProcedure or surgery
Also called Dynamic splint
custom-made dynamic splinting with more early active exercises intervention.
custom-made protective hand splintProcedure or surgery
Also called resting hand splint
Immobilization splint with gentle ROM exercises
physical therapy and occupational therapyOther
both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Immobilization programs | Placebo comparator | custom-made protective hand splint physical therapy and occupational therapy Receives: 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 Receives: Procedure: custom-made dynamic hand splint; Other: physical therapy and occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in motor function
QuickDASH quesrtionnaire for upper extremity
Measured: baseline, three months and six months
Secondary outcomes (4)
Functional MRI
"GE" Nuclear Magnetic Resonance Imaging System GE Medical Systems, LLC
Measured: baseline, three months and six months
wrist pain
visual analog scale
Measured: baseline, three months and six months
wrist sensory
light touch, pin prick, position sense
Measured: baseline, three months and six months
wrist range of motion
goniometer
Measured: baseline, three months and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startAug 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Hand InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Yu Chi, Bachelor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465840
- Sponsor's protocol ID
- CMRPG8D0931
- Status last verified
- Aug 2016
- First submitted
- 16 Dec 2014
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no available now
Publications
Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.
PubMed 15882604Chesney A, Chauhan A, Kattan A, Farrokhyar F, Thoma A. Systematic review of flexor tendon rehabilitation protocols in zone II of the hand. Plast Reconstr Surg. 2011 Apr;127(4):1583-1592. doi: 10.1097/PRS.0b013e318208d28e.
PubMed 21187807Karen Pettengill, MS, OTR/L, CHT, Gwendolyn Van Strien, LPT, MSC. Postoperative Management of Flexor Tendon Injuries
Diane Cifaldi Collins, Laurie Schwarze, Early progressive resistance following immobilization of flexor tendon repairs. July-September 1991, Pages 111-116
Duran RJ, House RG. Controlled passive motion following flexor tendon repairs in zone 2and 3. In: American Academy of Orthopedic Surgeons: Symposium on Tendon Surgery in the Hand. St. Louis : CV Mosby Co.; 1975
Iwuagwu FC, McGrouther DA. Early cellular response in tendon injury: the effect of loading. Plast Reconstr Surg. 1998 Nov;102(6):2064-71. doi: 10.1097/00006534-199811000-00038.
PubMed 9811004Evans RB, Thompson DE. The application of force to the healing tendon. J Hand Ther. 1993 Oct-Dec;6(4):266-84. doi: 10.1016/s0894-1130(12)80328-0.
PubMed 8124441Bunnell S. Repair of nerves and tendons of the hand. J Bone Joint Surg 1928; 10:1
Trumble TE, Vedder NB, Seiler JG 3rd, Hanel DP, Diao E, Pettrone S. Zone-II flexor tendon repair: a randomized prospective trial of active place-and-hold therapy compared with passive motion therapy. J Bone Joint Surg Am. 2010 Jun;92(6):1381-9. doi: 10.2106/JBJS.H.00927.
PubMed 20516313Tang JB. Clinical outcomes associated with flexor tendon repair. Hand Clin. 2005 May;21(2):199-210. doi: 10.1016/j.hcl.2004.11.005.
PubMed 15882599Hundozi H, Murtezani A, Hysenaj V, Hysenaj V, Mustafa A. Rehabilitation after surgery repair of flexor tendon injuries of the hand with Kleinert early passive mobilization protocol. Med Arch. 2013;67(2):115-9. doi: 10.5455/medarh.2013.67.115-119.
PubMed 24341058Tang JB. Indications, methods, postoperative motion and outcome evaluation of primary flexor tendon repairs in Zone 2. J Hand Surg Eur Vol. 2007 Apr;32(2):118-29. doi: 10.1016/J.JHSB.2006.12.009. Epub 2007 Feb 12.
PubMed 17298858Kleinert HE, Kutz JE, Atasoy E, Stormo A. Primary repair of flexor tendons. Orthop Clin North Am. 1973 Oct;4(4):865-76. No abstract available.
PubMed 4598164Lister GD, Kleinert HE, Kutz JE, Atasoy E. Primary flexor tendon repair followed by immediate controlled mobilization. J Hand Surg Am. 1977 Nov;2(6):441-51. doi: 10.1016/s0363-5023(77)80025-7.
PubMed 336675Strickland JW. Flexor tendon injuries. Part 1. Anatomy, physiology, biomechanics, healing, and adhesion formation around a repaired tendon. Orthop Rev. 1986 Oct;15(10):632-45.
PubMed 3331174
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Outcome and Brain Functional MRI of Hand Injury Patients After Different Rehabilitation Programs
- ClinicalTrials.gov ID
- NCT02465840
- Acronym / sponsor ID
- CMRPG8D0931
- Conditions
- Hand Injury
- Keywords
- rehabilitation, functional MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Jun 2015 (estimated)
- 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.
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.
Detailed description
Rehabilitation regimen is a noninvasive therapy for hand injured patients after operation. Protected active/passive motion is the mostly used method. Rehabilitation therapy could provide pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma. The investigators will collect 40 patients with hand trauma after operation and 10 normal subjects in this study. These 40 patients were divided into 2 experimental groups: 20 patients in group A ( immobilization program) and 20 patients in group B (Kleinert program).
A.The immobilization program 0-4 week: dorsal prospective splint in the wrist and MCP joint flexion and IP joint full extension.
3-4 weeks: Hourly: 10 repetitions of passive digital flexion and extension with wrist at 10ﾟextension. Hourly: 10 repetitions of active tendon gliding exercises.
4-6 weeks: dorsal blocking splint discontinued. Gentle blocking exercises initiated 10 repetitions, 4-6 times daily added to passive flexion and tendon gliding.
6-8 weeks: gentle resistive exercise being and progresses gradually. B.The Kleinert program 0-3 day: dorsal protective splint applied with wrist and MCP joints in flexion and IP joints in full extension; elastic traction from fingernail, through palmar pulley, to volar forearm. Velcro strap to allow night release of elastic traction, splinting IPs in full extension.
0-4 weeks: hourly active extension to limits of splint, followed by flexion with elastic traction only. Wound and scar management and education. 4-6 weeks: dorsal protective splint discontinued, sometimes replaced with wrist cuff and elastic traction. Night protective splint to prevent flexion contracture. Active wrist and gentle active fisting initiated unless signs of minimal adhesions. At 6 weeks blocking exercises begin.
6-8 weeks: progressive resistive exercises begin. The investigators will perform the physical examination, brain fMRI, and QuickDASH questionnaire for each patient before the program, 3 and 6 months later. Functional magnetic resonance imaging (fMRI) will be also performed in normal participants.
All patients will perform rehabilitation with 2-3 sessions per week. The investigators will perform the physical examination, brain fMRI, and QuickDASH questionnaire for each patient before the program, 3 and 6 months later. Functional magnetic resonance imaging (fMRI) will be also performed in normal participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilization programs | Placebo comparator | Procedure: custom-made protective hand splint, Other: physical therapy and occupational therapycustom-made protective hand splint physical therapy and occupational therapy |
| Kleinert programs | Experimental | Procedure: custom-made dynamic hand splint, Other: physical therapy and occupational therapycustom-made dynamic hand splint physical therapy and occupational therapy |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients have a hand trauma injury after operation (< 3 months)
Key exclusion criteria (5 listed)
- previous history of hand injury
- infection disease; arthritis
- systemic neuromuscular disease
- single tendon injury.
- central nerve system disorder
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 |
|---|---|---|
| custom-made dynamic hand splintAlso: Dynamic splintcustom-made dynamic splinting with more early active exercises intervention. | Procedure or surgery | Kleinert programs |
| custom-made protective hand splintAlso: resting hand splintImmobilization splint with gentle ROM exercises | Procedure or surgery | Immobilization programs |
| physical therapy and occupational therapyboth the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week. | Other | Immobilization programs, Kleinert programs |
Primary outcome
change from baseline in motor function
Time frame: baseline, three months and six months
QuickDASH quesrtionnaire for upper extremity
4 secondary outcomes
Functional MRI
Time frame: baseline, three months and six months
wrist pain
Time frame: baseline, three months and six months
wrist sensory
Time frame: baseline, three months and six months
wrist range of motion
Time frame: baseline, three months and six months
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 24 Jul 2018.
- Background: PubMed 15882604Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.
- Background: PubMed 21187807Chesney A, Chauhan A, Kattan A, Farrokhyar F, Thoma A. Systematic review of flexor tendon rehabilitation protocols in zone II of the hand. Plast Reconstr Surg. 2011 Apr;127(4):1583-1592. doi: 10.1097/PRS.0b013e318208d28e.
- BackgroundKaren Pettengill, MS, OTR/L, CHT, Gwendolyn Van Strien, LPT, MSC. Postoperative Management of Flexor Tendon Injuries
- BackgroundDiane Cifaldi Collins, Laurie Schwarze, Early progressive resistance following immobilization of flexor tendon repairs. July-September 1991, Pages 111-116
- BackgroundDuran RJ, House RG. Controlled passive motion following flexor tendon repairs in zone 2and 3. In: American Academy of Orthopedic Surgeons: Symposium on Tendon Surgery in the Hand. St. Louis : CV Mosby Co.; 1975
- Background: PubMed 9811004Iwuagwu FC, McGrouther DA. Early cellular response in tendon injury: the effect of loading. Plast Reconstr Surg. 1998 Nov;102(6):2064-71. doi: 10.1097/00006534-199811000-00038.
- Background: PubMed 8124441Evans RB, Thompson DE. The application of force to the healing tendon. J Hand Ther. 1993 Oct-Dec;6(4):266-84. doi: 10.1016/s0894-1130(12)80328-0.
- BackgroundBunnell S. Repair of nerves and tendons of the hand. J Bone Joint Surg 1928; 10:1
- Background: PubMed 20516313Trumble TE, Vedder NB, Seiler JG 3rd, Hanel DP, Diao E, Pettrone S. Zone-II flexor tendon repair: a randomized prospective trial of active place-and-hold therapy compared with passive motion therapy. J Bone Joint Surg Am. 2010 Jun;92(6):1381-9. doi: 10.2106/JBJS.H.00927.
- Background: PubMed 15882599Tang JB. Clinical outcomes associated with flexor tendon repair. Hand Clin. 2005 May;21(2):199-210. doi: 10.1016/j.hcl.2004.11.005.
- Background: PubMed 24341058Hundozi H, Murtezani A, Hysenaj V, Hysenaj V, Mustafa A. Rehabilitation after surgery repair of flexor tendon injuries of the hand with Kleinert early passive mobilization protocol. Med Arch. 2013;67(2):115-9. doi: 10.5455/medarh.2013.67.115-119.
- Background: PubMed 17298858Tang JB. Indications, methods, postoperative motion and outcome evaluation of primary flexor tendon repairs in Zone 2. J Hand Surg Eur Vol. 2007 Apr;32(2):118-29. doi: 10.1016/J.JHSB.2006.12.009. Epub 2007 Feb 12.
- Individual participant dataSharing planned: No. no available now
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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.
Huang Yu Chi, Bachelor principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing custom-made dynamic hand splint, custom-made protective hand splint and physical therapy and occupational therapy in people with Hand Injury, run by Chang Gung Memorial Hospital.
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 5 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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
change from baseline in motor function (time frame: baseline, three months and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02465840, which also lists 26 linked publications.
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 24 Jul 2018.