Peripheral Nerve Injury at Forearm Level (Diagnosis)NCT04087577
Effects of Motor Learning After Upper Limb Peripheral Nerve Injury
A study testing conventional physical therapy and mirror therapy in people with Peripheral Nerve Injury at Forearm Level (Diagnosis), run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Peripheral Nerve Injury at Forearm Level (Diagnosis)
- What is being tested?
- conventional physical therapy and mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Dec 2019to 28 Feb 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign the inform consent
- Sufficiently communicate in the Chinese language
- Be able to follow instructions
- Newly median, ulnar, or radial nerve repair at forearm level in recent 3 weeks
Who cannot join
- Pregnant or breast-feeding woman
- Central nervous disease
- A history of nerve entrapment syndrome in recent 1 year
- Patients with a history of latent neuropathy, such as diabetes, dialysis, and tumor
- Unable to communicate or comprehend the questionnaires
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
Taoyuan, 333
Chang Gung Memorial Hospital
Taoyuan
About this study
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration.
Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life
Read the detailed description
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration.
Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life. This research aims to explore the effects of mirror therapy for peripheral nerve injury. We will enroll 60 patients who suffer from median, ulnar or radial nerve injury at the level of elbow or proximal forearm. The subjects will be randomized into the mirror-therapy group or the control group. Each group will receive conventional physical therapy (i.e., electrical stimulation, joint range of motion exercise, muscle strengthening training, sensory reeducation training). The mirror-therapy group would be supplemented by motor learning by mirror therapy. The measurements include joint range of motion, pain status, sensibility, grip strength, pinch strength, hand function test and the Disabilities of the Arm, Shoulder and Hand (DASH). Demographic information will be collected and analyzed by the independent t-tests. The outcome variables taken during the three and six months after the interventions would be included. One-way ANOVA are used to compare the difference between measurements. This study may offer an evidence based results to explore the effects of mirror therapy for peripheral nerve regeneration and motor learning.
- Being tested
- conventional physical therapy, mirror therapy
- Keywords
- peripheral nerve injury, motor learning, mirror therapy, physical therapy
- Medical subject headings
- Disease, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues, sensory relearning
mirror therapyOther
mirror therapy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | conventional physical therapy with mirror therapy Receives: Other: conventional physical therapy; Other: mirror therapy |
| control group | Active comparator | conventional physical therapy Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months
force in grams
Measured: baseline, 3 months, 6 months
change from baseline in two-point discrimination (2PD) at 3 and 6 months
S0-4, higher score indicates better outcome
Measured: baseline, 3 months, 6 months
change from baseline in grip power at 3 and 6 months
grip power in kilograms
Measured: baseline, 3 months, 6 months
Secondary outcomes (4)
change from baseline in upper-extremity functional outcomes at 3 and 6 months
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire ranges from 0-100. Lower score indicates better outcomes.
Measured: baseline, 3 months, 6 months
Minnesota rate of manipulation tests
Manipulation tests in seconds
Measured: baseline, 3 months and 6 months
Purdue Pegboard Test
Manipulation tests in seconds
Measured: baseline, 3 months and 6 months
functional MRI activation
movement and sensory tests to calcuate z-score by software
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start19 Dec 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Injury at Forearm Level (Diagnosis)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh-Hsia Chen, Master, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087577
- Sponsor's protocol ID
- 201900433A3
- Status last verified
- Jul 2020
- First submitted
- 26 Aug 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Learning After Upper Limb Peripheral Nerve Injury
- ClinicalTrials.gov ID
- NCT04087577
- Acronym / sponsor ID
- 201900433A3
- Keywords
- peripheral nerve injury, motor learning, mirror therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Sep 2019 (actual)
- 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.
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration.
Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life
Detailed description
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration.
Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life. This research aims to explore the effects of mirror therapy for peripheral nerve injury. We will enroll 60 patients who suffer from median, ulnar or radial nerve injury at the level of elbow or proximal forearm. The subjects will be randomized into the mirror-therapy group or the control group. Each group will receive conventional physical therapy (i.e., electrical stimulation, joint range of motion exercise, muscle strengthening training, sensory reeducation training). The mirror-therapy group would be supplemented by motor learning by mirror therapy. The measurements include joint range of motion, pain status, sensibility, grip strength, pinch strength, hand function test and the Disabilities of the Arm, Shoulder and Hand (DASH). Demographic information will be collected and analyzed by the independent t-tests. The outcome variables taken during the three and six months after the interventions would be included. One-way ANOVA are used to compare the difference between measurements. This study may offer an evidence based results to explore the effects of mirror therapy for peripheral nerve regeneration and motor learning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: conventional physical therapy, Other: mirror therapyconventional physical therapy with mirror therapy |
| control group | Active comparator | Other: conventional physical therapyconventional physical therapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to sign the inform consent
- Sufficiently communicate in the Chinese language
- Be able to follow instructions
- Newly median, ulnar, or radial nerve repair at forearm level in recent 3 weeks
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding woman
- Central nervous disease
- A history of nerve entrapment syndrome in recent 1 year
- Patients with a history of latent neuropathy, such as diabetes, dialysis, and tumor
- Unable to communicate or comprehend the questionnaires
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 |
|---|---|---|
| conventional physical therapyincludes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues, sensory relearning | Other | control group, experimental group |
| mirror therapymirror therapy | Other | experimental group |
Primary outcome
change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months
Time frame: baseline, 3 months, 6 months
force in grams
change from baseline in two-point discrimination (2PD) at 3 and 6 months
Time frame: baseline, 3 months, 6 months
S0-4, higher score indicates better outcome
change from baseline in grip power at 3 and 6 months
Time frame: baseline, 3 months, 6 months
grip power in kilograms
4 secondary outcomes
change from baseline in upper-extremity functional outcomes at 3 and 6 months
Time frame: baseline, 3 months, 6 months
Minnesota rate of manipulation tests
Time frame: baseline, 3 months and 6 months
Purdue Pegboard Test
Time frame: baseline, 3 months and 6 months
functional MRI activation
Time frame: 3 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 2 Aug 2021.
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.
Yueh-Hsia Chen, Master principal investigator
Chang Gung Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy and mirror therapy in people with Peripheral Nerve Injury at Forearm Level (Diagnosis), run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 4 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Semmes-Weinstei monofilaments (SWM) at 3 and 6 months (time frame: baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2021.