Stroke, IschemicNCT05506826
Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.
A study testing fine motor activities and conventional therapy and mirror therapy in people with Stroke, Ischemic and Acute Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
to compare the effects of the Mirror therapy and fine motor activities on hand function in chronic stroke patients Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke, Ischemic, Acute Pain, Weakness, Muscle
- What is being tested?
- fine motor activities and conventional therapy and mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 20 Aug 2022
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A score greater than 24 on the Mini-Mental State examination test
- Chronic stroke patients whose episode of stroke onset was 6 months to 2 years.
- Patients who are able to communicate well and grasp the therapist's spoken instructions
Who cannot join
- Patients who have restricted joint movement in their healthy upper extremities.
- Neglect syndrome or a visual field deficiency
- Patients with recurrent stroke.
- Spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
to compare the effects of the Mirror therapy and fine motor activities on hand function in chronic stroke patients
Read the detailed description
This study will be conducted to compare the effects of mirror therapy and fine motor activities in chronic stroke patients. Total Twenty eight hemiplegic patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation centre Lahore and Mian Munshi Hospital Lahore (DHQ). The patients will randomly assigned to a mirror therapy group (n=14) and Fine motor activities group (n=14). The patients in both groups will undergo conventional therapy for 4 weeks (60minutes/day, 5 days/week). The patients will be evaluated at the beginning and end of the treatment by Fugl- Meyer Aassessment (FMA) wolf motor assessment scale and the Functional Independence Measure (FIM). After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.
- Conditions
- Stroke, Ischemic, Acute Pain, Weakness, Muscle
- Being tested
- fine motor activities, conventional therapy and mirror therapy
- Keywords
- Stroke, Ischemic, Acute Pain, Weakness, Muscle
- Medical subject headings
- Ischemic Stroke, Acute Pain, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fine motor activitiesOther
patient will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy
conventional therapy and mirror therapyOther
Patients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb
| Study group | Role | What they receive |
|---|---|---|
| fine motor activities group | Experimental | Patients in this group will receive conventional therapy for 1 month sixty minutes/day, 5 days/week in addition to performing fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes Receives: Other: fine motor activities |
| control group | Active comparator | Patients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb Receives: Other: conventional therapy and mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
fugl mayer assessment FMA upper limb
For stroke patients, the Fugal-Meyer Assessment (FMA) is a performance-based impairment measure. It is used to assess balance, motor function, sensation, and joint function in persons who suffer hemiplegia after a stroke. In both clinical and research settings, it is used to identify sickness severity, define motor recovery, and plan and assess treatment
Measured: 9 months
The Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is a non-diagnostic disability assessment instrument that was developed for a wide range of groups
Measured: 9 months
The Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test (WMFT) uses timed and functional tasks to assess upper limb motor skills
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Jan 2022
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Model description
- Study participants will be divided in two groups. Patients in group A will receive conventional therapy for four weeks sixty minutes per day, five days per week. In Group B patients will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506826
- Sponsor's protocol ID
- REC/RCR & AHS/21/0254
- Status last verified
- Nov 2022
- First submitted
- 17 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hillis AE. Developments in treating the nonmotor symptoms of stroke. Expert Rev Neurother. 2020 Jun;20(6):567-576. doi: 10.1080/14737175.2020.1763173. Epub 2020 May 12.
PubMed 32363957Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
PubMed 32103968Umeki N, Murata J, Higashijima M. Effects of Training for Finger Perception on Functional Recovery of Hemiplegic Upper Limbs in Acute Stroke Patients. Occup Ther Int. 2019 Nov 4;2019:6508261. doi: 10.1155/2019/6508261. eCollection 2019.
PubMed 31777474Fong KNK, Ting KH, Chan CCH, Li LSW. Mirror therapy with bilateral arm training for hemiplegic upper extremity motor functions in patients with chronic stroke. Hong Kong Med J. 2019 Feb;25 Suppl 3(1):30-34. No abstract available.
PubMed 30792371
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.
- ClinicalTrials.gov ID
- NCT05506826
- Acronym / sponsor ID
- REC/RCR & AHS/21/0254
- Conditions
- Stroke, Ischemic, Acute Pain, Weakness, Muscle
- Keywords
- Stroke, Ischemic, Acute Pain, Weakness, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 18 Aug 2022 (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.
to compare the effects of the Mirror therapy and fine motor activities on hand function in chronic stroke patients
Detailed description
This study will be conducted to compare the effects of mirror therapy and fine motor activities in chronic stroke patients. Total Twenty eight hemiplegic patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation centre Lahore and Mian Munshi Hospital Lahore (DHQ). The patients will randomly assigned to a mirror therapy group (n=14) and Fine motor activities group (n=14). The patients in both groups will undergo conventional therapy for 4 weeks (60minutes/day, 5 days/week). The patients will be evaluated at the beginning and end of the treatment by Fugl- Meyer Aassessment (FMA) wolf motor assessment scale and the Functional Independence Measure (FIM). After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be divided in two groups. Patients in group A will receive conventional therapy for four weeks sixty minutes per day, five days per week. In Group B patients will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy
| Arm | Type | Receives |
|---|---|---|
| fine motor activities group | Experimental | Other: fine motor activitiesPatients in this group will receive conventional therapy for 1 month sixty minutes/day, 5 days/week in addition to performing fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes |
| control group | Active comparator | Other: conventional therapy and mirror therapyPatients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A score greater than 24 on the Mini-Mental State examination test
- Chronic stroke patients whose episode of stroke onset was 6 months to 2 years.
- Patients who are able to communicate well and grasp the therapist's spoken instructions
Key exclusion criteria (4 listed)
- Patients who have restricted joint movement in their healthy upper extremities.
- Neglect syndrome or a visual field deficiency
- Patients with recurrent stroke.
- Spine surgery.
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 |
|---|---|---|
| fine motor activitiespatient will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy | Other | fine motor activities group |
| conventional therapy and mirror therapyPatients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb | Other | control group |
Primary outcome
fugl mayer assessment FMA upper limb
Time frame: 9 months
For stroke patients, the Fugal-Meyer Assessment (FMA) is a performance-based impairment measure. It is used to assess balance, motor function, sensation, and joint function in persons who suffer hemiplegia after a stroke. In both clinical and research settings, it is used to identify sickness severity, define motor recovery, and plan and assess treatment
The Functional Independence Measure (FIM)
Time frame: 9 months
The Functional Independence Measure (FIM) is a non-diagnostic disability assessment instrument that was developed for a wide range of groups
The Wolf Motor Function Test (WMFT)
Time frame: 9 months
The Wolf Motor Function Test (WMFT) uses timed and functional tasks to assess upper limb motor skills
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 9 Nov 2022.
- Background: PubMed 32363957Hillis AE. Developments in treating the nonmotor symptoms of stroke. Expert Rev Neurother. 2020 Jun;20(6):567-576. doi: 10.1080/14737175.2020.1763173. Epub 2020 May 12.
- Background: PubMed 32103968Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
- Background: PubMed 31777474Umeki N, Murata J, Higashijima M. Effects of Training for Finger Perception on Functional Recovery of Hemiplegic Upper Limbs in Acute Stroke Patients. Occup Ther Int. 2019 Nov 4;2019:6508261. doi: 10.1155/2019/6508261. eCollection 2019.
- Background: PubMed 30792371Fong KNK, Ting KH, Chan CCH, Li LSW. Mirror therapy with bilateral arm training for hemiplegic upper extremity motor functions in patients with chronic stroke. Hong Kong Med J. 2019 Feb;25 Suppl 3(1):30-34. No abstract available.
- 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.
zeest hashmi, MSNMPT 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 fine motor activities and conventional therapy and mirror therapy in people with Stroke, Ischemic and Acute Pain, 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 3 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: finished, as of the sponsor's last update on 9 Nov 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 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?
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 mayer assessment FMA upper limb (time frame: 9 months). 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 NCT05506826, which also lists 4 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 9 Nov 2022.