StrokeNCT06459336
Comparative Effects of Intensive and Distributed CIMT on Upper Extremity Function in Stroke Patients
A study testing Intensive constraint-induced movement therapy and Distributed constraint-induced movement therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intensive constraint-induced movement therapy and Distributed constraint-induced movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- ischemic or hemorrhagic stroke
- Both genders eligible
- Gcs score ≥ 13
- Able to extend at least 10° at the fingers
- Able to extend at least 20° at the wrist
- Patients diagnosed with one side more affected(hemiplegia)
- Modified Ashworth scale score ≤2
Who cannot join
- severe, chronic systemic illness
- Epilepsy
- History of fall past 6 months
- Injections of botulinum toxin type A or operations on the UE within 6 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Hameed Latif Hospital
Lahore, Punjab Province, 54000
Wajiha Shahid, Phd, +92-321-4885079, wajiha.shahid@riphah.edu.pk
Rabia Hussain, MsPT(NMPT)
About this study
Official title: Comparative Effects of Intensive and Distributed Constraint-induced Movement Therapy on Upper Extremity Function in Stroke Patients
The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.
Read the detailed description
Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke
- Conditions
- Stroke
- Being tested
- Intensive constraint-induced movement therapy, Distributed constraint-induced movement therapy
- Keywords
- Stroke, upper extremity function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive constraint-induced movement therapyOther
Intensive protocol of CIMT will be given for 6hrs for 6 days to make total of 36 hours
Distributed constraint-induced movement therapyOther
Distributed protocol of CIMT will be given for 2.25hrs two times a week for 8 weeks making total of 36 hours
| Study group | Role | What they receive |
|---|---|---|
| Intensive constraint-induced movement therapy | Experimental | intensive protocol of CIMT of total 36 hours will be given in a week Receives: Other: Intensive constraint-induced movement therapy |
| Distributed constraint-induced movement therapy | Experimental | Distributed participants will total of 36 hours treatment for 8 weeks Receives: Other: Distributed constraint-induced movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-Upper Extremity
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Measured: 8th week
Wolf motor function test
This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The original version of this test was developed by Dr. Steven L. Wolf, Emory University School of Medicine. The original version consisted of 21 items; the widely used version of the wolf motor function test consists of 17 items. it uses a Uses a 6-point ordinal scale i.e."0" means "does not attempt with the involved arm" to "5" means "arm does participate; movement appears to be normal."
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Mar 2024
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
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 StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459336
- Sponsor's protocol ID
- REC/RCR & AHS/23/0279
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Effects of Intensive Versus Distributed Constraint-Induced Movement Therapy for Children With Unilateral Cerebral Palsy: A Quasi-Randomized Trial. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):109-118. doi: 10.1177/15459683231162330. Epub 2023 Mar 28.
PubMed 36987387Kaneko T, Maeda M, Yokoyama H, Kai S, Obuchi K, Takase S, Horimoto T, Shimada R, Moriya T, Ohmae H, Amanai M, Okita Y, Takebayashi T. Therapeutic effect of adjuvant therapy added to constraint-induced movement therapy in patients with subacute to chronic stroke: a systematic review and meta-analysis. Disabil Rehabil. 2024 Sep;46(18):4098-4112. doi: 10.1080/09638288.2023.2269843. Epub 2023 Oct 19.
PubMed 37855247
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Intensive and Distributed Constraint-induced Movement Therapy on Upper Extremity Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT06459336
- Acronym / sponsor ID
- REC/RCR & AHS/23/0279
- Conditions
- Stroke
- Keywords
- Stroke, upper extremity function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Jun 2024 (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 main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.
Detailed description
Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive constraint-induced movement therapy | Experimental | Other: Intensive constraint-induced movement therapyintensive protocol of CIMT of total 36 hours will be given in a week |
| Distributed constraint-induced movement therapy | Experimental | Other: Distributed constraint-induced movement therapyDistributed participants will total of 36 hours treatment for 8 weeks |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40-70 years
- ischemic or hemorrhagic stroke
- Both genders eligible
- Gcs score ≥ 13
- Able to extend at least 10° at the fingers
Key exclusion criteria (4 listed)
- severe, chronic systemic illness
- Epilepsy
- History of fall past 6 months
- Injections of botulinum toxin type A or operations on the UE within 6 months
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 |
|---|---|---|
| Intensive constraint-induced movement therapyIntensive protocol of CIMT will be given for 6hrs for 6 days to make total of 36 hours | Other | Intensive constraint-induced movement therapy |
| Distributed constraint-induced movement therapyDistributed protocol of CIMT will be given for 2.25hrs two times a week for 8 weeks making total of 36 hours | Other | Distributed constraint-induced movement therapy |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity
Time frame: 8th week
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Wolf motor function test
Time frame: 8th week
This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The original version of this test was developed by Dr. Steven L. Wolf, Emory University School of Medicine. The original version consisted of 21 items; the widely used version of the wolf motor function test consists of 17 items. it uses a Uses a 6-point ordinal scale i.e."0" means "does not attempt with the involved arm" to "5" means "arm does participate; movement appears to be normal."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 36987387Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Effects of Intensive Versus Distributed Constraint-Induced Movement Therapy for Children With Unilateral Cerebral Palsy: A Quasi-Randomized Trial. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):109-118. doi: 10.1177/15459683231162330. Epub 2023 Mar 28.
- Background: PubMed 37855247Kaneko T, Maeda M, Yokoyama H, Kai S, Obuchi K, Takase S, Horimoto T, Shimada R, Moriya T, Ohmae H, Amanai M, Okita Y, Takebayashi T. Therapeutic effect of adjuvant therapy added to constraint-induced movement therapy in patients with subacute to chronic stroke: a systematic review and meta-analysis. Disabil Rehabil. 2024 Sep;46(18):4098-4112. doi: 10.1080/09638288.2023.2269843. Epub 2023 Oct 19.
- 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.
Wajiha Shahid, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive constraint-induced movement therapy and Distributed constraint-induced movement therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 8 inclusion and 4 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 14 Jun 2024. 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 Pakistan. 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 Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment-Upper Extremity (time frame: 8th week). 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?
On the ClinicalTrials.gov record for NCT06459336, 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 14 Jun 2024; AzTrials last refreshed its copy on 5 Nov 2026.