Joint Loose BodiesNCT02932631
Different Methods of Physical Therapy for Stroke
A study of Joint Loose Bodies, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
It is estimated that worldwide, about 15 million people are affected by vascular accident (CVA) per year, and in Brazil, the stroke is a major cause of death and disability, generating too much economic and social impact by generating motor sequelae , sensory and cognitive arising from blockage or rupture of blood… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Loose Bodies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Jul 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- will be included in the study volunteers with stroke diagnosis for six months or more lesions.
- showing hemiparesis
- with at least 20 of passive extension handle and 10 for the fingers (TREVISAN; TRINTINAGLIA, 2010)
- who are aged between 45 and 80 years
- independent of race, color and cultural socioeconomic status, that are experiencing higher score to 24 points on the MMSE, which are not performing physical therapy at the time of the study and who agree and sign the consent form.
Who cannot join
- volunteers with a diagnosis of stroke at least six months
- stroke recurrence
- double hemiparesis
- hemiplegia, which present associated diseases
- uncontrolled hypertension according to the Brazilian Guidelines on Hypertension (systolic blood pressure (BP)> 90 and <140 diastolic pressure (DP )> 50 and <90) and heart rate (HR) 80-100 bpm
- respiratory rate (RR) from 18 to 20 rpm, with 36 temperature, diabetes, heart disease, apraxia, aphasia, that are experiencing pain and deformities upper limb, that are experiencing cognitive impairment, visual and hearing impairment, which will be assessed using the Mini Mental State Examination -MEEM tests (Appendix a) with scores below 24 points or taking into account score for illiterates, Jaeger Card (ANNEX B) and Test Whisper (ANNEX C) respectively
- who performs physical therapy at the time of the study, who do not agree and refuse to sign the Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF CONSTRAINT-INDUCED MOVEMENT THERAPY Versus CONVENTIONAL PHYSICAL THERAPY ON FUNCTIONAL RECOVERY AND QUALITY OF LIFE AFTER STROKE
It is estimated that worldwide, about 15 million people are affected by vascular accident (CVA) per year, and in Brazil, the stroke is a major cause of death and disability, generating too much economic and social impact by generating motor sequelae , sensory and cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the hemiparesis, which affects about 80% of cases with consequent impairment of the quality of life of individuals. However, physical therapy has shown to facilitate return of the function of these individuals, while minimizing the sensorimotor deficits for promoting neuronal plasticity through the motor relearning. Among the features of physical therapy are the conventional physical therapy techniques, Therapy and Restriction of Movement Induction (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare the application of conventional physiotherapy protocols and TRIM and / or mental practice on the morphometric features, functionality and quality of life of post-stroke hemiparetic subjects in the chronic phase. 60 volunteers will be selected, of both sexes, aged between 45 and 80 years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase were divided into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice group (GPM) and group TRIM + Mental Practice (GTPM) to perform specific exercises for each group for three times a week, totaling 24 sessions. Volunteers will be evaluated in four times through the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the Upper Limb (THMMS) and to assess the Quality of Life will be used Quality Scale Specific Life Vascular Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting blood and electromyography for muscular activity. After the research data will be tabulated on an Excel spreadsheet to perform intergroup and intragroup comparisons between the four evaluation times, which will be used for data analysis the BioEstat® 5.2 program, the choice of tests for analysis dependent on the statistical distribution types found and the homogeneity of their variances.
Read the detailed description
The sample is composed of 60 volunteers of both sexes, with a clinical diagnosis of stroke (CVA) with injury over six months time that characterizes the chronic stage of the disease and present hemiparesis in upper limb.
PROCEDURES AND DATA COLLECTION
The research will be divided into the following steps:
STAGE 1: The search will begin with an invitation to volunteers to participate in the study, through posters and verbal invitation. Then, a pre-selection candidates by applying MMSE will be performed, Jaeger card and Whisper test in order to evaluate the existence of cognitive impairment, visual and auditory respectively. If they can make up the sample, volunteers will be selected as meeting the inclusion and exclusion criteria, and researchers will deliver two-way the IC explaining how occur the research objectives of the Office and application of the Protocol and deliver two-way also statement of photographs and footage authorization for display permit photos and footage. It is noteworthy that both routes of the term and Declaration will be signed on every page by volunteers, which will be a copy of each document with the same.
Prior to the procedures and data collection, the researchers will be trained in the application of all instruments of evaluation and handling of resources to be used in the treatment of volunteers.
2nd STAGE: Volunteers will be evaluated through the scale application of FMA and THMMS in order to analyze the functionality and ability of MS and QOL will be assessed by EQVE-stroke as described in materials in this methodology.
The amplitude of the paretic upper limb movement will also be assessed by goniometry scapulohumeral humeral joint, shoulder, elbow, wrist, thumb interphalangeal and where use of a universal manual goniometer and another smaller toward the measuring fingers. The first measure goniometric be obtained after the patient's arrival in treatment- place in the pre-treatment. The following measures will be during treatment (12 ° session) and the immediate and late stages after the treatment. To perform such a procedure will be asked to volunteers who remain supine on a stretcher, followed by the sitting position in a chair, the latter should position the upper limb aligned to the trunk and forearm to be evaluated on a small table, a neutral pronation and supination with the elbow held in 90 ° of flexion.
3rd STAGE: Next muscle electromyographic activity will be measured by electromyography apparatus of Miotec ®.
Volunteers will conduct the test in a well-lit room with adequate ventilation and environment without noise, which will be placed in the sitting position with arm supported on fixed surface and so will surface electrodes connected on the paretic upper limb having as guidance for positioning electrodes muscular motor points previously located by an electrical stimulator and coupled with a conductive gel, so as to promote a more stable transitions and tendon insertions in order to quantitatively analyze the information sent nerve member.
The investigators will be asked to volunteer to perform three isometric contractions for four seconds each with two intervals between contractions two minutes, and asked each contraction the patient to reach its maximum strength. The muscles to be analyzed will be the flexors of fingers flexors wrist flexor ulnar elbow flexors, shoulder flexors and internal rotators of the shoulder, the answers will be measured and displayed on a computer screen that will be BIOPAC ® system.
4th STAGE: As for the functional range of the MS paretic will be measured by the functional reach test, adapted to the sitting position, in which the individual will be sitting without armrest in the chair for the upper limb, positioned laterally to the wall, with shoulder 15 cm away from this without touching it at any time, with feet parallel in a comfortable position, keeping the shoulder near the wall flexed to 90 °. A tape measure is fixed parallel to the floor, positioned at the height of the acromion. The volunteer will then be instructed to lean forward as much as possible; the displacement to be measured on the tape with three attempts functional range, then obtaining the average of the three.
5th STEP: Then, for the collection of handgrip strength in paretic MS will be used hydraulic dynamometer handgrip Jamar® where with volunteers in the sitting position in the bed, standing with the shoulder in neutral position, elbows and wrist in 90 ° neutral position, the therapist will support the dynamometer. Volunteers will be instructed to perform three handgrip maneuvers reaching maximum voluntary contraction with each hand, with one-minute interval between one operation and another. After the collection will be the simple arithmetic average entrees the three measures collected.
These procedures in the study will take place in four stages: before the start of treatment that correspond to the pre-treatment; after the 12th session that correspond to intermediate treatment; immediately after the 24th session, which will correspond to the immediate post-treatment; and the total intervention time equal to 24 sessions, which will be distributed in three weekly sessions held on alternate days (Monday, Wednesday and Friday). After evaluating the functionality evaluation of oxidative stress. Initially it will be collected blood with a sterile needle through the lancing on the medial side of the digital pulp of the fourth finger of the left hand, which will be pre-cleaned with 70% alcohol. The collection of blood drop will be made with a razor through five light taps of this blade with the drop microscopy. After this, at room temperature (23 ° C), the blade will be kept in place protected from contact with the blood of nine minutes for the realization of the collected blood clotting process. At the end of this period, the morphology of these clots is microscopically observed under a 40X magnification.
Morphological evaluation of oxidative stress in plasm blood be evaluated according to the test known as Optical Microscopy for cell analysis in vitro or HLB test, also known under the designation of Dry layer oxidative test, which will be referred to as microscopic morphology oxidative stress in plasm (EEW).
The EEW provides indirect information on to oxidative stress, among others, using the following grading system the percentage of the discontinuous area of clot present in microscope slide: grade I (normal oxidative stress rate, with total area of discontinuous extracellular matrix (ME) less than 10%), grade II (mild stress, with ME discontinuity area between 10 to 20%), grade III (moderate stress with ME discontinuity the area between 20 30%), grade IV (severe stress, with ME discontinuity area between 30 to 40%) and the grade V (very severe stress, with the ME discontinuity area above 40%).
The respective assigned qualitative graduation will be logged into a spreadsheet for further analysis statistics. As a measure of standardization, the observation of morphological patterns of different clots will be performed by one of the researchers associated with assessment by OxyScanner the so-called program developed and marketed by Aldea Global Soluciones® (SFA), which give a copy of the software.
This evaluation will be done in four stages, which will use throughout the process coats, disposable gloves and masks, and will be held by only one of the researchers, in order to avoid bias in the research.
- Conditions
- Joint Loose Bodies
- Being tested
- THERAPY CONTROL AND MOVEMENT OF INDUCTION
- Keywords
- hemiparesis, STROKE, neural plasticity, PHYSICAL THERAPY
- Medical subject headings
- Joint Loose Bodies, Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAPY CONTROL AND MOVEMENT OF INDUCTIONOther
Also called PRACTICING MENTAL THERAPY, CONVENTIONAL PHYSICAL THERAPY
Volunteers conventional physiotherapy group will stretching, strengthening and / or mobilization and functional training of the affected muscles with 3 sets of 10 repetitions for 60 minutes.
The restriction therapy group and induction motion the volunteers will wear a brace on the top healthy member to be restricted in each session during the exercises for this group for a period of 60 minutes, encouraging tasks involving activities of daily living and / or daily. In group practice mental, the volunteers listen to a CD that in the first two minutes, will promote progressive relaxation where imaginary in a calm and quiet place followed by 13 minutes of listening to the restriction therapy exercise protocol and motion induction. The association group practices and mental restriction therapy, volunteer listens to the CD for 15 minutes following the same procedures mentioned in group practice mental, followed by exercises functional activities for 45 minutes in the paretic limb.
| Study group | Role | What they receive |
|---|---|---|
| CONVENTIONAL PHYSICAL THERAPY group | Active comparator | physical exercises divided into three phases:
1. stretching, strengthening and/or mobilization;
2. functional training of the affected muscles;
3. functional training of the paretic limb. Receives: Other: THERAPY CONTROL AND MOVEMENT OF INDUCTION |
| containment therapy induced | Experimental | healthy side is restricted with splinting and exercises in hemiparetic member: carry out functional tasks individually. Each task will be held for 5 minutes, totaling 60 minutes of service Receives: Other: THERAPY CONTROL AND MOVEMENT OF INDUCTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
electromyography
For the evaluation of electrical muscle activity through electromyography through surface electrodes analyzed musculatures flexors and wrist extensors and elbow (median frequency, raw).
Measured: pre-treatment and after 8 weeks
motor skills in the upper limbs
For evaluating the functionality of the Fugl-Meyer Assessment Scale was developed with the objective of evaluating six aspects of the patient, range of motion and pain, motor function, sensitivity, balance, coordination and speed. But the Motor Ability Test of the Upper Limb (THMMS) to measure quantitative and qualitative aspects of ADLs involving the upper limb in patients who have suffered strokes.Scales do not have measurement units only get a total points.
Measured: pre-treatment and after 8 weeks
quality of life
Quality of Life Scale for Stroke (EQVE-AVE) which consists of 49 items, divided into 12 areas divided into energy, family role, language, mobility, humor, For the assessment of quality of life will be used Specific personality, self-care, social role, reasoning, upper limb function (MS), vision and work / productivity. Will be evaluated pre-treatment and after 24 sessions.
Measured: pre-treatment and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Joint Loose BodiesStudies 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
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larissa Salgado de Oliveira Rocha, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932631
- Sponsor's protocol ID
- 41597715.9.0000.5174
- Status last verified
- Oct 2016
- First submitted
- 6 Sep 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liepert J, Uhde I, Graf S, Leidner O, Weiller C. Motor cortex plasticity during forced-use therapy in stroke patients: a preliminary study. J Neurol. 2001 Apr;248(4):315-21. doi: 10.1007/s004150170207.
PubMed 11374097Jackson PL, Lafleur MF, Malouin F, Richards C, Doyon J. Potential role of mental practice using motor imagery in neurologic rehabilitation. Arch Phys Med Rehabil. 2001 Aug;82(8):1133-41. doi: 10.1053/apmr.2001.24286.
PubMed 11494195
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF CONSTRAINT-INDUCED MOVEMENT THERAPY Versus CONVENTIONAL PHYSICAL THERAPY ON FUNCTIONAL RECOVERY AND QUALITY OF LIFE AFTER STROKE
- ClinicalTrials.gov ID
- NCT02932631
- Acronym / sponsor ID
- 41597715.9.0000.5174
- Conditions
- Joint Loose Bodies
- Keywords
- hemiparesis, STROKE, neural plasticity, PHYSICAL THERAPY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Oct 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.
It is estimated that worldwide, about 15 million people are affected by vascular accident (CVA) per year, and in Brazil, the stroke is a major cause of death and disability, generating too much economic and social impact by generating motor sequelae , sensory and cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the hemiparesis, which affects about 80% of cases with consequent impairment of the quality of life of individuals. However, physical therapy has shown to facilitate return of the function of these individuals, while minimizing the sensorimotor deficits for promoting neuronal plasticity through the motor relearning. Among the features of physical therapy are the conventional physical therapy techniques, Therapy and Restriction of Movement Induction (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare the application of conventional physiotherapy protocols and TRIM and / or mental practice on the morphometric features, functionality and quality of life of post-stroke hemiparetic subjects in the chronic phase. 60 volunteers will be selected, of both sexes, aged between 45 and 80 years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase were divided into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice group (GPM) and group TRIM + Mental Practice (GTPM) to perform specific exercises for each group for three times a week, totaling 24 sessions. Volunteers will be evaluated in four times through the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the Upper Limb (THMMS) and to assess the Quality of Life will be used Quality Scale Specific Life Vascular Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting blood and electromyography for muscular activity. After the research data will be tabulated on an Excel spreadsheet to perform intergroup and intragroup comparisons between the four evaluation times, which will be used for data analysis the BioEstat® 5.2 program, the choice of tests for analysis dependent on the statistical distribution types found and the homogeneity of their variances.
Detailed description
The sample is composed of 60 volunteers of both sexes, with a clinical diagnosis of stroke (CVA) with injury over six months time that characterizes the chronic stage of the disease and present hemiparesis in upper limb.
PROCEDURES AND DATA COLLECTION
The research will be divided into the following steps:
STAGE 1: The search will begin with an invitation to volunteers to participate in the study, through posters and verbal invitation. Then, a pre-selection candidates by applying MMSE will be performed, Jaeger card and Whisper test in order to evaluate the existence of cognitive impairment, visual and auditory respectively. If they can make up the sample, volunteers will be selected as meeting the inclusion and exclusion criteria, and researchers will deliver two-way the IC explaining how occur the research objectives of the Office and application of the Protocol and deliver two-way also statement of photographs and footage authorization for display permit photos and footage. It is noteworthy that both routes of the term and Declaration will be signed on every page by volunteers, which will be a copy of each document with the same.
Prior to the procedures and data collection, the researchers will be trained in the application of all instruments of evaluation and handling of resources to be used in the treatment of volunteers.
2nd STAGE: Volunteers will be evaluated through the scale application of FMA and THMMS in order to analyze the functionality and ability of MS and QOL will be assessed by EQVE-stroke as described in materials in this methodology.
The amplitude of the paretic upper limb movement will also be assessed by goniometry scapulohumeral humeral joint, shoulder, elbow, wrist, thumb interphalangeal and where use of a universal manual goniometer and another smaller toward the measuring fingers. The first measure goniometric be obtained after the patient's arrival in treatment- place in the pre-treatment. The following measures will be during treatment (12 ° session) and the immediate and late stages after the treatment. To perform such a procedure will be asked to volunteers who remain supine on a stretcher, followed by the sitting position in a chair, the latter should position the upper limb aligned to the trunk and forearm to be evaluated on a small table, a neutral pronation and supination with the elbow held in 90 ° of flexion.
3rd STAGE: Next muscle electromyographic activity will be measured by electromyography apparatus of Miotec ®.
Volunteers will conduct the test in a well-lit room with adequate ventilation and environment without noise, which will be placed in the sitting position with arm supported on fixed surface and so will surface electrodes connected on the paretic upper limb having as guidance for positioning electrodes muscular motor points previously located by an electrical stimulator and coupled with a conductive gel, so as to promote a more stable transitions and tendon insertions in order to quantitatively analyze the information sent nerve member.
The investigators will be asked to volunteer to perform three isometric contractions for four seconds each with two intervals between contractions two minutes, and asked each contraction the patient to reach its maximum strength. The muscles to be analyzed will be the flexors of fingers flexors wrist flexor ulnar elbow flexors, shoulder flexors and internal rotators of the shoulder, the answers will be measured and displayed on a computer screen that will be BIOPAC ® system.
4th STAGE: As for the functional range of the MS paretic will be measured by the functional reach test, adapted to the sitting position, in which the individual will be sitting without armrest in the chair for the upper limb, positioned laterally to the wall, with shoulder 15 cm away from this without touching it at any time, with feet parallel in a comfortable position, keeping the shoulder near the wall flexed to 90 °. A tape measure is fixed parallel to the floor, positioned at the height of the acromion. The volunteer will then be instructed to lean forward as much as possible; the displacement to be measured on the tape with three attempts functional range, then obtaining the average of the three.
5th STEP: Then, for the collection of handgrip strength in paretic MS will be used hydraulic dynamometer handgrip Jamar® where with volunteers in the sitting position in the bed, standing with the shoulder in neutral position, elbows and wrist in 90 ° neutral position, the therapist will support the dynamometer. Volunteers will be instructed to perform three handgrip maneuvers reaching maximum voluntary contraction with each hand, with one-minute interval between one operation and another. After the collection will be the simple arithmetic average entrees the three measures collected.
These procedures in the study will take place in four stages: before the start of treatment that correspond to the pre-treatment; after the 12th session that correspond to intermediate treatment; immediately after the 24th session, which will correspond to the immediate post-treatment; and the total intervention time equal to 24 sessions, which will be distributed in three weekly sessions held on alternate days (Monday, Wednesday and Friday). After evaluating the functionality evaluation of oxidative stress. Initially it will be collected blood with a sterile needle through the lancing on the medial side of the digital pulp of the fourth finger of the left hand, which will be pre-cleaned with 70% alcohol. The collection of blood drop will be made with a razor through five light taps of this blade with the drop microscopy. After this, at room temperature (23 ° C), the blade will be kept in place protected from contact with the blood of nine minutes for the realization of the collected blood clotting process. At the end of this period, the morphology of these clots is microscopically observed under a 40X magnification.
Morphological evaluation of oxidative stress in plasm blood be evaluated according to the test known as Optical Microscopy for cell analysis in vitro or HLB test, also known under the designation of Dry layer oxidative test, which will be referred to as microscopic morphology oxidative stress in plasm (EEW).
The EEW provides indirect information on to oxidative stress, among others, using the following grading system the percentage of the discontinuous area of clot present in microscope slide: grade I (normal oxidative stress rate, with total area of discontinuous extracellular matrix (ME) less than 10%), grade II (mild stress, with ME discontinuity area between 10 to 20%), grade III (moderate stress with ME discontinuity the area between 20 30%), grade IV (severe stress, with ME discontinuity area between 30 to 40%) and the grade V (very severe stress, with the ME discontinuity area above 40%).
The respective assigned qualitative graduation will be logged into a spreadsheet for further analysis statistics. As a measure of standardization, the observation of morphological patterns of different clots will be performed by one of the researchers associated with assessment by OxyScanner the so-called program developed and marketed by Aldea Global Soluciones® (SFA), which give a copy of the software.
This evaluation will be done in four stages, which will use throughout the process coats, disposable gloves and masks, and will be held by only one of the researchers, in order to avoid bias in the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONVENTIONAL PHYSICAL THERAPY group | Active comparator | Other: THERAPY CONTROL AND MOVEMENT OF INDUCTIONphysical exercises divided into three phases: 1. stretching, strengthening and/or mobilization; 2. functional training of the affected muscles; 3. functional training of the paretic limb. |
| containment therapy induced | Experimental | Other: THERAPY CONTROL AND MOVEMENT OF INDUCTIONhealthy side is restricted with splinting and exercises in hemiparetic member: carry out functional tasks individually. Each task will be held for 5 minutes, totaling 60 minutes of service |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- will be included in the study volunteers with stroke diagnosis for six months or more lesions.
- showing hemiparesis
- with at least 20 of passive extension handle and 10 for the fingers (TREVISAN; TRINTINAGLIA, 2010)
- who are aged between 45 and 80 years
- independent of race, color and cultural socioeconomic status, that are experiencing higher score to 24 points on the MMSE, which are not performing physical therapy at the time of the study and who agree and sign the consent form.
Key exclusion criteria (7 listed)
- volunteers with a diagnosis of stroke at least six months
- stroke recurrence
- double hemiparesis
- hemiplegia, which present associated diseases
- uncontrolled hypertension according to the Brazilian Guidelines on Hypertension (systolic blood pressure (BP)> 90 and <140 diastolic pressure (DP )> 50 and <90) and heart rate (HR) 80-100 bpm
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 |
|---|---|---|
| THERAPY CONTROL AND MOVEMENT OF INDUCTIONAlso: PRACTICING MENTAL THERAPY, CONVENTIONAL PHYSICAL THERAPYVolunteers conventional physiotherapy group will stretching, strengthening and / or mobilization and functional training of the affected muscles with 3 sets of 10 repetitions for 60 minutes. The restriction therapy group and induction motion the volunteers will wear a brace on the top healthy member to be restricted in each session during the exercises for this group for a period of 60 minutes, encouraging tasks involving activities of daily living and / or daily. In group practice mental, the volunteers listen to a CD that in the first two minutes, will promote progressive relaxation where imaginary in a calm and quiet place followed by 13 minutes of listening to the restriction therapy exercise protocol and motion induction. The association group practices and mental restriction therapy, volunteer listens to the CD for 15 minutes following the same procedures mentioned in group practice mental, followed by exercises functional activities for 45 minutes in the paretic limb. | Other | CONVENTIONAL PHYSICAL THERAPY group, containment therapy induced |
Primary outcome
electromyography
Time frame: pre-treatment and after 8 weeks
For the evaluation of electrical muscle activity through electromyography through surface electrodes analyzed musculatures flexors and wrist extensors and elbow (median frequency, raw).
motor skills in the upper limbs
Time frame: pre-treatment and after 8 weeks
For evaluating the functionality of the Fugl-Meyer Assessment Scale was developed with the objective of evaluating six aspects of the patient, range of motion and pain, motor function, sensitivity, balance, coordination and speed. But the Motor Ability Test of the Upper Limb (THMMS) to measure quantitative and qualitative aspects of ADLs involving the upper limb in patients who have suffered strokes.Scales do not have measurement units only get a total points.
quality of life
Time frame: pre-treatment and after 8 weeks
Quality of Life Scale for Stroke (EQVE-AVE) which consists of 49 items, divided into 12 areas divided into energy, family role, language, mobility, humor, For the assessment of quality of life will be used Specific personality, self-care, social role, reasoning, upper limb function (MS), vision and work / productivity. Will be evaluated pre-treatment and after 24 sessions.
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 30 Jan 2018.
- Results publication: PubMed 11374097Liepert J, Uhde I, Graf S, Leidner O, Weiller C. Motor cortex plasticity during forced-use therapy in stroke patients: a preliminary study. J Neurol. 2001 Apr;248(4):315-21. doi: 10.1007/s004150170207.
- Results publication: PubMed 11494195Jackson PL, Lafleur MF, Malouin F, Richards C, Doyon J. Potential role of mental practice using motor imagery in neurologic rehabilitation. Arch Phys Med Rehabil. 2001 Aug;82(8):1133-41. doi: 10.1053/apmr.2001.24286.
- 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.
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 of Joint Loose Bodies, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
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 5 inclusion and 7 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 30 Jan 2018. 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 Brazil. 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?
electromyography (time frame: pre-treatment and after 8 weeks). 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?
On the ClinicalTrials.gov record for NCT02932631, which also lists 2 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 30 Jan 2018.