StrokeNCT04873908
Effects of Modified Constraint-Induced on Chronic Stroke Patients
A study testing modified constraint-induced therapy, Proprioceptive Training and conventional rehabilitation in people with Stroke and Rehabilitation, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- modified constraint-induced therapy, Proprioceptive Training and conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2021to 20 Sep 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post stroke hemiparetic patients of six months
- spasticity ≤ Grade -3 on modified Ashworth scale
- those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
- a score of 24 or higher on the Modified Mini-Mental State Examination
- no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale
Who cannot join
- Patients with history of previous stroke,
- angina,
- uncontrolled hypertension, on medication that could impair neuromuscular performance,
- wrist or finger pathologies, significant visual or hearing impairment,
- balance problems which may compromise safety during sound upper limb constraint,
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study
In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.
- Conditions
- Stroke, Rehabilitation
- Being tested
- modified constraint-induced therapy, Proprioceptive Training, conventional rehabilitation
- Keywords
- Modified constraint-induced therapy, Proprioceptive Training, conventional rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified constraint-induced therapyOther
Patients received conventional rehabilitation and modified constraint-induced therapy schedule
Proprioceptive TrainingOther
Patients received conventional rehabilitation and Proprioceptive Training schedule
conventional rehabilitationOther
Patients received conventional rehabilitation schedule
| Study group | Role | What they receive |
|---|---|---|
| conventional rehabilitation | Other | Not described Receives: Other: conventional rehabilitation |
| Modified constraint-induced therapy | Experimental | Not described Receives: Other: modified constraint-induced therapy |
| Proprioceptive Training | Experimental | Not described Receives: Other: Proprioceptive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment test
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm
Measured: Score change after 6 weeks of intervention compared to baseline
Action Research arm test
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm
Measured: Score change after 6 weeks of intervention compared to baseline
Motor Activity Log
Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm
Measured: Score change after 6 weeks of intervention compared to baseline
Secondary outcomes (2)
Modified Ashworth Scale
Modified Ashworth Scale was measure muscle spasticity. It is among the most commonly used scales for clinical and research purposes. The resistance against passive movement is evaluated on a scale of 0-4 points.The lower total score means better spasticity in the arm
Measured: Score change after 6 weeks of intervention compared to baseline
thumb localizing test
A proprioception examination, called the 'thumb localizing test' (TLT), is described as a technique for testing 'limb localization'. With the patient's eyes closed, the examiner positions one of the patient's upper limbs (fixed limb) and asks him to pinch the thumb of that limb with the opposite thumb and index finger (reaching limb).It is evaluated on a 0-3 point scale. The lower the total score, the better the proprioceptive in the arm.
Measured: Score change after 6 weeks of intervention compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start5 May 2021
- Primary completion15 Jul 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873908
- Sponsor's protocol ID
- 2020-24/05
- Status last verified
- Oct 2021
- First submitted
- 30 Apr 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04873908
- Acronym / sponsor ID
- 2020-24/05
- Conditions
- Stroke, Rehabilitation
- Keywords
- Modified constraint-induced therapy, Proprioceptive Training, conventional rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 5 May 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.
In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional rehabilitation | Other | Other: conventional rehabilitation |
| Modified constraint-induced therapy | Experimental | Other: modified constraint-induced therapy |
| Proprioceptive Training | Experimental | Other: Proprioceptive Training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post stroke hemiparetic patients of six months
- spasticity ≤ Grade -3 on modified Ashworth scale
- those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
- a score of 24 or higher on the Modified Mini-Mental State Examination
- no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale
Key exclusion criteria (6 listed)
- Patients with history of previous stroke,
- angina,
- uncontrolled hypertension, on medication that could impair neuromuscular performance,
- wrist or finger pathologies, significant visual or hearing impairment,
- balance problems which may compromise safety during sound upper limb constraint,
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 |
|---|---|---|
| modified constraint-induced therapyPatients received conventional rehabilitation and modified constraint-induced therapy schedule | Other | Modified constraint-induced therapy |
| Proprioceptive TrainingPatients received conventional rehabilitation and Proprioceptive Training schedule | Other | Proprioceptive Training |
| conventional rehabilitationPatients received conventional rehabilitation schedule | Other | conventional rehabilitation |
Primary outcome
Fugl-Meyer assessment test
Time frame: Score change after 6 weeks of intervention compared to baseline
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm
Action Research arm test
Time frame: Score change after 6 weeks of intervention compared to baseline
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm
Motor Activity Log
Time frame: Score change after 6 weeks of intervention compared to baseline
Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm
2 secondary outcomes
Modified Ashworth Scale
Time frame: Score change after 6 weeks of intervention compared to baseline
thumb localizing test
Time frame: Score change after 6 weeks of intervention compared to baseline
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 15 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 modified constraint-induced therapy, Proprioceptive Training and conventional rehabilitation in people with Stroke and Rehabilitation, run by Acibadem University at 1 site in Turkey (Türkiye).
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 6 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 15 Oct 2021. 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 Turkey (Türkiye). 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?
Fugl-Meyer assessment test (time frame: Score change after 6 weeks of intervention compared to baseline). 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 15 Oct 2021.