Parkinson DiseaseNCT04815382
Effects of a Dynamic Upper Limb Orthosis in Patients With Parkinson's Disease
A study testing Dynamic Upper Limb Orthosis in people with Parkinson Disease and Tremor, Limb, run by Universidad de Burgos at 1 site in Spain.
Trial summary
This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease, Tremor, Limb, Rigidity, Muscle
- What is being tested?
- Dynamic Upper Limb Orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 30 Apr 2023
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease according to "brain bank" criteria
- Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale
Who cannot join
- Moderate cognitive or language impairment
- Musculoskeletal or dermatological diseases in the upper limb
- Impossibility of follow-up for 6 months
- Difficulty to attend to assessment visits
- Allergy to glove composition
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitary of Burgos
Burgos, 09006
Raul Soto-Cámara, PhD, +34 673192039, rscamara@ubu.es
Jeronimo Gonzalez-Bernal, PhD, +34 947499108, jejavier@ubu.es
About this study
Official title: Effects of a Dynamic Upper Limb Orthosis in Reducing Tremor and Rigidity on Patients With Parkinson's Disease: a Randomized Clinical Test Study Protocol
This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity
Read the detailed description
Objective: To assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in Parkinson patients.
Design and setting: A randomized controlled clinical trial of two parallel groups.
Population: 40 patients with tremor and stiffness due to Parkinson´s disease will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the Burgos University Hospital (Spain)
. Measurements and intervention: Functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. All participants will continue to receive the medical treatment indicated to their health status. The intervention group will receive a treatment based on a dynamic orthosis during 3 months. No additional intervention with the participants of the control group will be completed.
- Conditions
- Parkinson Disease, Tremor, Limb, Rigidity, Muscle
- Being tested
- Dynamic Upper Limb Orthosis
- Keywords
- Parkinson Disease, Tremor, Rigidity, Upper Limb, Dynamic Orthosis
- Medical subject headings
- Parkinson Disease, Tremor, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Upper Limb OrthosisOther
The dynamic upper limb orthosis extends from subdeltoid level to 10 mm distal to the metacarpal-phalangeal joints. The orthosis will be tailored to include 20 degrees of wrist extension and to abduct the thumb. They made from nylon and lycra.
The orthosis will be used throughout the day, being removed when the patient lies down.
The orthosis will be used during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Upper Limb Orthosis group | Experimental | The dynamic upper limb orthosis group will receive a treatment based on the use of a dynamic upper limb orthosis.
Participants of this group will continue to receive their regular therapy Receives: Other: Dynamic Upper Limb Orthosis |
| Control group | No intervention | The control group will not receive any type of intervention Participants of this group will continue to receive their regular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rigidity of the upper limb
Measurement by the Movement Disorders. Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Subscale III Score between 0 (best functionality) and 68 (worst functionality)
Measured: 3 months
Tremor of the upper limb
Measurement by the Kinesia One Device This device will provide information on the speed, amplitude and rhythm of the tremor of the upper limb. There are no minimum or maximum values
Measured: 3 months
Secondary outcomes (3)
Manual dexterity of the upper limb
Measurement by the Purdue Pegboard Test Reference values according to age, sex and type of activity
Measured: 3 months
Daily Living Activities
Measurement by the Movement Disorders. Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Subscale II Score between 0 (best functionality) and 52 (worst functionality)
Measured: 3 months
Emotional state and quality of life.
Measurement by the Parkinson's Disease Questionnaire (PDQ-39) The patient points out the frequency of presentation of different situations. It is a quantitative variable; there are no minimum or maximum values; there are no reference values
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 posted25 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Raúl Soto-Cámara, PhD, Principal investigator, University of BurgosJeronimo Javier González-Bernal, PhD, Principal investigator, University of Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815382
- Sponsor's protocol ID
- UBU-HUBU: DO
- Status last verified
- Jun 2022
- First submitted
- 22 Mar 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dynamic Upper Limb Orthosis in Reducing Tremor and Rigidity on Patients With Parkinson's Disease: a Randomized Clinical Test Study Protocol
- ClinicalTrials.gov ID
- NCT04815382
- Acronym / sponsor ID
- UBU-HUBU: DO
- Conditions
- Parkinson Disease, Tremor, Limb, Rigidity, Muscle
- Keywords
- Parkinson Disease, Tremor, Rigidity, Upper Limb, Dynamic Orthosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 25 Mar 2021 (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.
This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity
Detailed description
Objective: To assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in Parkinson patients.
Design and setting: A randomized controlled clinical trial of two parallel groups.
Population: 40 patients with tremor and stiffness due to Parkinson´s disease will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the Burgos University Hospital (Spain)
. Measurements and intervention: Functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. All participants will continue to receive the medical treatment indicated to their health status. The intervention group will receive a treatment based on a dynamic orthosis during 3 months. No additional intervention with the participants of the control group will be completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Upper Limb Orthosis group | Experimental | Other: Dynamic Upper Limb OrthosisThe dynamic upper limb orthosis group will receive a treatment based on the use of a dynamic upper limb orthosis. Participants of this group will continue to receive their regular therapy |
| Control group | No intervention | –The control group will not receive any type of intervention Participants of this group will continue to receive their regular therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Parkinson's disease according to "brain bank" criteria
- Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale
Key exclusion criteria (5 listed)
- Moderate cognitive or language impairment
- Musculoskeletal or dermatological diseases in the upper limb
- Impossibility of follow-up for 6 months
- Difficulty to attend to assessment visits
- Allergy to glove composition
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 |
|---|---|---|
| Dynamic Upper Limb OrthosisThe dynamic upper limb orthosis extends from subdeltoid level to 10 mm distal to the metacarpal-phalangeal joints. The orthosis will be tailored to include 20 degrees of wrist extension and to abduct the thumb. They made from nylon and lycra. The orthosis will be used throughout the day, being removed when the patient lies down. The orthosis will be used during 3 months | Other | Dynamic Upper Limb Orthosis group |
Primary outcome
Rigidity of the upper limb
Time frame: 3 months
Measurement by the Movement Disorders. Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Subscale III Score between 0 (best functionality) and 68 (worst functionality)
Tremor of the upper limb
Time frame: 3 months
Measurement by the Kinesia One Device This device will provide information on the speed, amplitude and rhythm of the tremor of the upper limb. There are no minimum or maximum values
3 secondary outcomes
Manual dexterity of the upper limb
Time frame: 3 months
Daily Living Activities
Time frame: 3 months
Emotional state and quality of life.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Raúl Soto-Cámara, PhD principal investigator
University of Burgos
Jeronimo Javier González-Bernal, PhD principal investigator
University of Burgos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Upper Limb Orthosis in people with Parkinson Disease and Tremor, Limb, run by Universidad de Burgos at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raúl Soto Cámar-, PhD (+34 673192039, rscamara@ubu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rigidity of the upper limb (time frame: 3 months). The study lists 2 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 27 Jun 2022.