An interventional study of Upper limb motor control training (uMCON) in Cognitive Impairment, sponsored by University of Nottingham. Recruiting at 1 site in United Kingdom. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by University of Nottingham · Not applicable, Interventional, and Supportive care
This healthy volunteer intervention study is designed to evaluate the effectiveness of upper limb motor control training (uMCT) on physical and cognitive functions in older adults. The primary objectives of the study are twofold:
Assess the Impact on Physical and Neuromuscular Function: The study seeks to determine whether uMCT positively influences physical performance, including motor coordination and neuromuscular function, in older adults.
Assessment the Impact on Cognitive Function: The study aims to investigate whether uMCT enhances cognitive abilities in older adults.
In addition to these main goals, the study will also assess the feasibility and safety of implementing uMCT in an older adult population.
The main questions it aims to answer are:
Does uMCON training have a positive effect on physical function and neuromuscular function in older adults?
Does uMCON training have a positive effect on cognitive function in older adults? The researchers designed this study to show whether uMCON training works on physical function (balance, gait, and so on) and cognition in older adults.
Participants will come to Derby Royal Hospital Medical School to attend uMCON training three days a week for 1 month. They will attend pre-training, post-training, and follow-up (after 1 month) control assessment sessions.
Experimental protocol
Participants:
This study will be carried out on 24 healthy participants (aged between 65-85 years), with an aim to recruit 50% males. Participants will be randomised (via sealed envelope) to the uMCT group or a no-intervention control group (PPI). Before enrolment on to the study, participants will complete a screening session which will include an electrocardiogram (ECG), blood pressure check, and general health questions, including previous medical history. This session will also provide potential participants an opportunity to ask any questions about the study that they may have after reading the participant information sheet (PIS). If an abnormal screening result is encountered, this will be discussed with the participant and their GP will be informed in writing. All participants will be informed in detail about the procedures and risks of the study via the PIS and the opportunity to ask questions, before their written informed consent is obtained.
Assessment sessions:
All participants will be requested to attend 3 assessment sessions, in addition to 4-weeks uMCT (3x/wk) for the intervention group. For participants in the PPI group (no intervention control group), they will also attend the research unit 3x/wk to participate in patient and public involvement (PPI) (in research) activities. These actives will include, as examples, discussion around the importance/relevance of upcoming studies, lay review of participant/patient facing documents, assistance with research dissemination. Given the primary endpoint of this study is cognition, this approach will mitigate the impact of any adaptation in the uMCT group being due to their regular in-person engagement with the research team as all participants will have this. It will also allow participants in the no-intervention group to feel that their time is productive and worthwhile.
The assessment sessions will take place:
Each of these sessions will be identical and will comprise:PPI
Each assessment session is expected to last a maximum of 3 hours, allowing sufficient time for explanation of each component at each visit.
Training Sessions:
uMCT will involve 3 sessions each week for 4 weeks based on elbow flexion. Each session will last \~20 minutes and will be fully supervised by a member of the research team. During each training session, participants will be asked to follow a sinusoidal force line on a screen by contracting their elbow flexors. Six to 10 different force tracking wave forms will be performed in each session at 10%, 25%, or 40% of MVC with an amplitude of ±2%, ±4%, or ±8%. Each wave form will last 20-30 seconds with 60 seconds of rest between each.
3,845 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 24 is below the median of 64 across 2,810 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Nottingham is the lead sponsor of 456 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Willing and able to give informed consent for participation in the study
Exclusion Criteria:
Diagnosis of cognitive impairment
uMCON training group
Other: Upper limb motor control training (uMCON)
The exercise program protocol was determined using elbow flexion (Biceps brachii) and elbow extension (Triceps) on a special platform developed for the arm. In this computer-based exercise, participants are asked to follow a small ball on the screen in different lines at certain percentages of maximum muscle strength (10%, 25%, 50%, and so on). Neuromuscular training will be worked on with this exercise.
Outcome Measure Title: Rate of participants whose cognition improved with upper limb motor control training.
Number of Participants: 20 Control group: No Rate of Female/Male: 50%/ 50% Time frame: 1 month upper limb neuromuscular training Assessment time: Pre-training, Post-training, Follow-up(after 4 weeks) Cognition questionnaire is used (MOCA).
Time frame: Baseline, 4 week, and 8 week
Clinically relevant functional outcomes (motor control, strength, dexterity, overall physical function)
* The nine-hole Peg Test to determine dexterity, * Isometric dynamometery to determine MVC for elbow flexion and knee extension (to assess non-joint specific adaptation), * Surface electromyography (sEMG) of the triceps brachii and intramusculer electromyography (iEMG) of vastus lateralis to determine muscle activation patterns (training specific and non-specific), * Simple (eyes open) and complex (eyes closed) balance tests, * Timed Up-and-Go (TUG) to determine mobility, * The Short Physcial Performace Battery (SPPB) to assess overall physical performance.
Time frame: Baseline, 4 week, and 8 week
Plasma pro/anti-inflammatory cytokine levels
Only a single blood sample (\<10ml) will be taken from participants at each assessment session via venepuncture. This will only be performed by an individual trained and competent in this technique. Blood samples will be centrifuged, and plasma stored at -20 to -80 degrees until batch-analysis at the end of the study.
Time frame: Baseline, 4 week, and 8 week
Plan to share: No — Access to personal (identifiable) information is limited only to research staff involved in the participation elements of this study, and to audit staff as detailed above.
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