Sensation DisordersNCT02768857
Effects of Early Sensory Reeducation Programs Using Mirror Therapy for Patients With Peripheral Nerve Injuries
A study testing Sensorimotor reeducation programs in people with Sensation Disorders and Motor Deficit, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This study evaluated the effects of an integrated program of touch-observation and task-based mirror therapy on sensorimotor function in nerve injury patients. Before the return of protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the participants received 15 minutes of mirror therapy… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sensation Disorders, Motor Deficit, Rehabilitation
- What is being tested?
- Sensorimotor reeducation programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2014to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- median or ulnar nerve injury,
- a combination of nerve and tendon or vascular injury,
- injury sites between the level of mid-palm and elbow, and
- the protective sensation of the hand is lacking or impaired.
Who cannot join
- patients with deficits in cognition or language comprehension, as well as severe limitations in the range of motion of the upper limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Touch-Observation and Task-based Mirror Therapy Protocol (MTPTOT) to Improve Sensorimotor Control and Functional Capability of Hands for Patients With Peripheral Nerve Injury
This study evaluated the effects of an integrated program of touch-observation and task-based mirror therapy on sensorimotor function in nerve injury patients. Before the return of protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session. Once the patients had regained the protective sense (Value of Semmes-Weinstein monofilament test < 4.31), the discriminative sensory reeducation program was started for the participants in both groups. The hypothesis was that using the mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield better results with regard to the returning of sensation, sensorimotor control ability and hand function than using a classical reeducation program alone.
- Conditions
- Sensation Disorders, Motor Deficit, Rehabilitation
- Being tested
- Sensorimotor reeducation programs
- Medical subject headings
- Sensation Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor reeducation programsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Early sensorimotor reeducation intervention | Experimental | The experimental group received 15 minutes of touch-observation and task-based mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session before the returning of the touch of a Semmes-Weinstein monofilament marked 4.31. Once the patients had regained the protective sense (SWM < 4.31), the mirror therapy program was replaced with a discriminative sensory reeducation program. Treatment duration was 12 weeks, at a frequency of three sessions per week. Receives: Behavioral: Sensorimotor reeducation programs |
| Traditional sensorimotor reeducation intervention | Active comparator | The control group received received 15 minutes traditional sensory reeducation program, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session before the returning of the touch of a Semmes-Weinstein monofilament marked 4.31. Once the patients had regained the protective sense (SWM < 4.31), the protective sensory reeducation program was replaced with a discriminative sensory reeducation program. Treatment duration was 12 weeks, at a frequency of three sessions per week. Receives: Behavioral: Sensorimotor reeducation programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks
Measured: baseline, 12 weeks and 24 weeks
Change from baseline result of Purdue pegboard test at 12 weeks and 24 weeks
Measured: baseline, 12 weeks and 24 weeks
Change from baseline result of Minnesota manual dexterity test at 12 weeks and 24 weeks
Measured: baseline, 12 weeks and 24 weeks
Change from baseline result of Pinch-holding-up-activity (PHUA) test at 12 weeks and 24 weeks
Measured: baseline, 12 weeks and 24 weeks
Secondary outcomes (1)
Change from baseline result of Static two-point discrimination (S2PD) test at 12 weeks and 24 weeks
Measured: baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensation DisordersStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768857
- Sponsor's protocol ID
- B-ER-102-389
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 16 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Touch-Observation and Task-based Mirror Therapy Protocol (MTPTOT) to Improve Sensorimotor Control and Functional Capability of Hands for Patients With Peripheral Nerve Injury
- ClinicalTrials.gov ID
- NCT02768857
- Acronym / sponsor ID
- B-ER-102-389
- Conditions
- Sensation Disorders, Motor Deficit, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 May 2016 (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.
This study evaluated the effects of an integrated program of touch-observation and task-based mirror therapy on sensorimotor function in nerve injury patients. Before the return of protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session. Once the patients had regained the protective sense (Value of Semmes-Weinstein monofilament test < 4.31), the discriminative sensory reeducation program was started for the participants in both groups. The hypothesis was that using the mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield better results with regard to the returning of sensation, sensorimotor control ability and hand function than using a classical reeducation program alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early sensorimotor reeducation intervention | Experimental | Behavioral: Sensorimotor reeducation programsThe experimental group received 15 minutes of touch-observation and task-based mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session before the returning of the touch of a Semmes-Weinstein monofilament marked 4.31. Once the patients had regained the protective sense (SWM < 4.31), the mirror therapy program was replaced with a discriminative sensory reeducation program. Treatment duration was 12 weeks, at a frequency of three sessions per week. |
| Traditional sensorimotor reeducation intervention | Active comparator | Behavioral: Sensorimotor reeducation programsThe control group received received 15 minutes traditional sensory reeducation program, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session before the returning of the touch of a Semmes-Weinstein monofilament marked 4.31. Once the patients had regained the protective sense (SWM < 4.31), the protective sensory reeducation program was replaced with a discriminative sensory reeducation program. Treatment duration was 12 weeks, at a frequency of three sessions per week. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- median or ulnar nerve injury,
- a combination of nerve and tendon or vascular injury,
- injury sites between the level of mid-palm and elbow, and
- the protective sensation of the hand is lacking or impaired.
Key exclusion criteria (1 listed)
- patients with deficits in cognition or language comprehension, as well as severe limitations in the range of motion of the upper limbs.
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 |
|---|---|---|
| Sensorimotor reeducation programs | Behavioural | Early sensorimotor reeducation intervention, Traditional sensorimotor reeducation intervention |
Primary outcome
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks
Time frame: baseline, 12 weeks and 24 weeks
Change from baseline result of Purdue pegboard test at 12 weeks and 24 weeks
Time frame: baseline, 12 weeks and 24 weeks
Change from baseline result of Minnesota manual dexterity test at 12 weeks and 24 weeks
Time frame: baseline, 12 weeks and 24 weeks
Change from baseline result of Pinch-holding-up-activity (PHUA) test at 12 weeks and 24 weeks
Time frame: baseline, 12 weeks and 24 weeks
1 secondary outcome
Change from baseline result of Static two-point discrimination (S2PD) test at 12 weeks and 24 weeks
Time frame: baseline, 12 weeks and 24 weeks
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 16 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor reeducation programs in people with Sensation Disorders and Motor Deficit, run by National Cheng-Kung University Hospital at 1 site 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 1 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks (time frame: baseline, 12 weeks and 24 weeks). The study lists 4 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 16 May 2016.