An interventional study of Standard Multidisciplinary Rehabilitation and Graded Motor Imagery (GMI) in Elbow Stiffess and Rehabilitation Treatment, sponsored by Centre Hospitalier de Valenciennes. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Centre Hospitalier de Valenciennes · Not applicable, Interventional, and Treatment
TRICEPS is a single-center, randomized, open-label, three-arm study evaluating two rehabilitation approaches for post-traumatic elbow stiffness in adults: Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF), each combined with standard care, compared with standard care alone.
A total of 75 adults aged 18 to 64 years with post-traumatic elbow stiffness following a fracture will be randomized in a 1:1:1 ratio to one of three groups: standard rehabilitation alone, standard rehabilitation combined with GMI, or standard rehabilitation combined with PNF. The treatment period will last 6 weeks.
The primary objective is to compare the effects of these rehabilitation approaches on upper-limb functional capacity, assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) score at baseline and after 6 weeks of treatment. Secondary outcomes include muscle strength, active joint range of motion, pain, kinesiophobia, and health-related quality of life.
Post-traumatic elbow stiffness is a frequent complication following elbow injury and may lead to substantial limitations in upper-limb function and activities of daily living. Conventional rehabilitation includes joint mobilization, stretching, strengthening, and functional exercises. Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) are rehabilitation approaches that may help improve movement and functional recovery. TRICEPS aims to compare these two approaches, when added to standard rehabilitation, with standard rehabilitation alone.
This is a prospective, single-center, randomized, open-label, controlled study with three parallel groups. A total of 75 adults aged 18 to 64 years with post-traumatic elbow stiffness following a fracture will be randomized equally to one of the following groups:
The treatment period lasts 6 weeks. After this period, participants continue rehabilitation according to usual clinical practice in the department.
The primary objective is to compare the effectiveness of GMI and PNF, each combined with standard care, with standard care alone in improving upper-limb functional capacity. The primary outcome is the Disabilities of the Arm, Shoulder and Hand (DASH) score, measured at baseline and after 6 weeks of treatment.
Secondary objectives are to compare the three groups with regard to muscle strength, active elbow and forearm range of motion, pain during rehabilitation, kinesiophobia, and health-related quality of life. Assessments are performed at baseline and after 6 weeks of treatment; additional follow-up assessments are performed 3 months after the end of treatment for the outcomes specified in the protocol.
The planned sample size is 75 participants, with 25 participants allocated to each group.
47 studies on the registry are indexed under Elbow Fractures; 13 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 29 interventional studies indexed under Elbow Fractures.
Browse Elbow Fractures studies →Centre Hospitalier de Valenciennes is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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Participants receive standard multidisciplinary rehabilitation for 6 weeks, including physiotherapy 5 times per week, occupational therapy 5 times per week, and a psychological assessment at the beginning of treatment. Participants also perform a prescribed independent exercise program for 20 to 30 minutes per day, 7 days per week. The rehabilitation program includes 30 minutes of physiotherapy with passive stretching, 30 minutes of occupational therapy focused on upper-limb function, and 30 minutes of independent exercises.
Other: Standard Multidisciplinary Rehabilitation
Participants receive standard multidisciplinary rehabilitation for 6 weeks, with Graded Motor Imagery (GMI) integrated into the rehabilitation program. The GMI intervention consists of three successive 2-week phases: left-right discrimination, imagined movements, and mirror-based visual feedback. The program includes 30 minutes of physiotherapy with passive stretching, 30 minutes of occupational therapy incorporating GMI, and 30 minutes of independent exercises. The total rehabilitation time is kept equivalent across the three study groups.
Other: Standard Multidisciplinary Rehabilitation · Behavioral: Graded Motor Imagery (GMI)
Participants receive standard multidisciplinary rehabilitation for 6 weeks, with Proprioceptive Neuromuscular Facilitation (PNF) using the Hold-Relax technique integrated into physiotherapy. PNF sessions are delivered by a physiotherapist 5 times per week and replace passive stretching within the 30-minute physiotherapy session. Participants also receive 30 minutes of occupational therapy focused on upper-limb function and perform 30 minutes of independent exercises. The total rehabilitation time is kept equivalent across the three study groups.
Other: Standard Multidisciplinary Rehabilitation · Other: Proprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax
Standard multidisciplinary rehabilitation over 6 weeks, consisting of physiotherapy 5 times per week, occupational therapy 5 times per week, a psychological assessment at the beginning of treatment, and a prescribed independent exercise program. Physiotherapy includes passive stretching, and occupational therapy focuses on upper-limb function. The total rehabilitation time is standardized across the three study groups.
Graded Motor Imagery (GMI) integrated into the rehabilitation program over 6 weeks, consisting of three successive 2-week phases: left-right discrimination, imagined movements, and mirror-based visual feedback. The intervention is incorporated into occupational therapy and replaces an equivalent amount of standard rehabilitation time as needed, without increasing the total rehabilitation time.
Proprioceptive Neuromuscular Facilitation (PNF) using the Hold-Relax technique, delivered by a trained physiotherapist 5 times per week over 6 weeks. The technique is integrated into the 30-minute physiotherapy session and replaces passive stretching. The total rehabilitation time remains equivalent to that of the standard care group.
Upper-limb functional capacity assessed by the DASH score at 6 weeks
Upper-limb functional capacity will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The DASH score at 6 weeks will be compared between the three study groups, with adjustment for the baseline DASH score.
Time frame: 6 weeks after treatment initiation
Upper-limb functional capacity assessed by the DASH score at 3 months after treatment
Upper-limb functional capacity will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to evaluate the maintenance of treatment effects and compare the three study groups.
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Isometric elbow flexor and extensor muscle strength at 6 weeks
Isometric strength of the elbow flexor and extensor muscles will be measured and compared between the three study groups.
Time frame: 6 weeks after treatment initiation
Isometric elbow flexor ans extensor muscle strength at 3-month follow-up
Isometric strength of the elbow flexor and extensor muscles will be measured to assess the maintenance of treatment effects and compared between the three study groups.
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Active elbow and forearm range of motion at 6 weeks
Active elbow flexion and extension and forearm pronation and supination will be measured to assess changes in joint range of motion.
Time frame: 6 weeks after treatment initiation
Active elbow and forearm range of motion at 3-month follow-up
Active elbow flexion and extension and forearm pronation and supination will be measured to assess the maintenance of treatment effects.
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Pain intensity before and after rehabilitation sessions
Pain intensity will be assessed using a 0-10 numeric rating scale immediately before and after each rehabilitation session. The difference between pre-session and post-session pain scores will be assessed.
Time frame: Before and immediately after each rehabilitation session during the 6-week treatment period
Pain intensity at 6 weeks
Pain intensity will be assessed using a 0-10 numeric rating scale to compare pain at the end of the treatment period between the three study groups.
Time frame: 6 weeks after treatment initiation
Pain intensity at 3-month follow-up
Pain intensity will be assessed using a 0-10 numeric rating scale to evaluate the maintenance of treatment effects.
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Kinesiophobia assessed by the short TAMPA scale at 6 weeks
Kinesiophobia will be assessed using the short version of the Tampa Scale to compare the effects of the three rehabilitation protocols after treatment.
Time frame: 6 weeks after treatment initiation
Kinesiophobia assessed by the short TAMPA scale at 3-month follow-up
Kinesiophobia will be assessed using the short version of the Tampa Scale to evaluate the maintenance of treatment effects.
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Health-related quality of life assessed by the EQ-5D-5L at 6 weeks
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, including the health profile, EQ-5D index score, and EQ visual analogue scale (EQ-VAS).
Time frame: 6 weeks after treatment initiation
Health-related quality of life assessed by the EQ-5D-5L at 3-month follow-up
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, including the health profile, EQ-5D index score, and EQ visual analogue scale (EQ-VAS), to evaluate the maintenance of treatment effects.
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Plan to share: No
Start is estimated for Dec 2026; primary completion for Nov 2030, 47 months later.
Of 15 interventional studies with no phase under Elbow Fractures, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 47 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier de Valenciennes